<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800212</url>
  </required_header>
  <id_info>
    <org_study_id>AMPULLOMA COHORT</org_study_id>
    <nct_id>NCT03800212</nct_id>
  </id_info>
  <brief_title>Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma</brief_title>
  <acronym>AMPULLOMA</acronym>
  <official_title>Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federation Francophone de Cancerologie Digestive</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federation Francophone de Cancerologie Digestive</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive&#xD;
      tumours. The only curative treatment is complete excision (surgical or endoscopic) of the&#xD;
      lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference&#xD;
      radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant&#xD;
      treatment is still debated: in view of the aggressive nature of the disease and the high&#xD;
      recurrence rate, it would appear appropriate to offer adjuvant treatment, although several&#xD;
      studies have failed to find any benefit on survival with post-operative radio-chemotherapy,&#xD;
      the most widely studied treatment at present, compared to excision alone. At present there&#xD;
      are no phase II studies specifically examining medical treatment of degenerated, inoperable&#xD;
      Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to&#xD;
      the treatments used for intestinal, pancreatic or biliary tumours, although neither one has&#xD;
      been shown to date to be superior to the other, nor have decision-making criteria been&#xD;
      clearly established.In conclusion, a national cohort study is proposed to undertake a&#xD;
      prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma&#xD;
      (particularly survival without recurrence and prognostic indicators for excised tumours and&#xD;
      the duration of disease control for tumours treated with palliative chemotherapy). The&#xD;
      treatment methods will be left to the free choice of the investigator and all patients may be&#xD;
      included, regardless of stage of their disease. In this study, freezing of tumour fragments&#xD;
      is encouraged, as this cohort will be supplemented by a later biological study. In order to&#xD;
      recruit sufficient patient numbers, the study will be based on participation of the&#xD;
      cooperative groups involved in the management of digestive cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive&#xD;
      tumours. In terms of incidence, it is the 3rd most common biliary tract tumour after&#xD;
      gallbladder cancer and common bile duct cancer. The incidence of ampullary adenocarcinoma is&#xD;
      not well known although it is estimated to be around 0.49 per 100,000 people. The known risk&#xD;
      factors are familial adenomatous polyposis (FAP) and Gardner's syndrome, HNPCC (Hereditary&#xD;
      Non-Polyposis Colorectal Cancer) syndrome, Peutz-Jeghers syndrome, Crohn's disease and&#xD;
      coeliac disease.&#xD;
&#xD;
      Except in its highly localised forms, ampulla of Vater carcinoma carries a poor prognosis. It&#xD;
      is a highly lymphophilic disease which commonly metastasises, particularly to the lymph nodes&#xD;
      and liver. The prognosis is however considerably better than that of pancreatic&#xD;
      adenocarcinoma. In one study which compared 71 ampullomas with 144 adenocarcinomas of&#xD;
      pancreatic head, the 5-year survival was 60% for the ampullary carcinomas compared to 20% for&#xD;
      pancreatic adenocarcinomas.&#xD;
&#xD;
      More generally, the 5-year survival rate in the literature is between 40-60% and, depending&#xD;
      on the study, 10-year survival is approximately 38% .&#xD;
&#xD;
      The only curative treatment is complete excision (surgical or endoscopic) of the lesions&#xD;
      which is possible in 80% of cases , with or without adjuvant treatment. The reference radical&#xD;
      treatment is cephalic duodenopancreatectomy (CDP). The 5-year survival rate in cases of&#xD;
      adenocarcinoma excised by CPD is in the region of 50%, rising to 60-70% if no lymph node&#xD;
      invasion is present, compared to 30% when lymph nodes are invaded and median survival is&#xD;
      approximately 4.5 years .&#xD;
&#xD;
      The indication for adjuvant treatment is still debated: in view of the aggressive nature of&#xD;
      the disease and the high recurrence rate, it would appear appropriate to offer adjuvant&#xD;
      treatment, although several studies have failed to find any benefit on survival with&#xD;
      post-operative radio-chemotherapy, the most widely studied treatment at present, compared to&#xD;
      excision alone . There is only one single randomised study comparing these two forms of&#xD;
      management, which shows no benefit in terms of 2 and 5-year survival, although only a small&#xD;
      number of patients had an ampullary tumour in this study . The conclusions of several&#xD;
      retrospective studies are more subtle, showing results in favour of adjuvant treatment in&#xD;
      patients with lymph node disease or a large tumour (T3/T4) .&#xD;
&#xD;
      Some groups have tested the merits of peroperative irradiation. It would appear that this&#xD;
      technique does not improve survival, although data on this subject are extremely patchy .&#xD;
&#xD;
      Administration of exclusive adjuvant chemotherapy has been examined in a single randomised&#xD;
      study. In this phase III study (ESPAC 3), median overall survival of patients who received&#xD;
      adjuvant chemotherapy with FUFOL Mayo for 6 months (n=101) or gemcitabine (n=98) was not&#xD;
      significantly improved compared to survival in patients undergoing surgery and not receiving&#xD;
      complementary treatment (57.1 versus 43 months, HR= 0.85, p=0.32). A subgroup analysis&#xD;
      suggested that the benefit of chemotherapy could be greater in the subgroup of patients with&#xD;
      RO resection (p= 0.057, 91% of cases).&#xD;
&#xD;
      Mean survival in patients suffering inoperable tumours is between 9 and 20.4 months depending&#xD;
      on the study .&#xD;
&#xD;
      It should be noted however that most of these studies have included tumours other than&#xD;
      ampullomas (particularly small bowel adenocarcinomas), making it more difficult to interpret&#xD;
      these results, and also that many are old results dating from before the era of modern&#xD;
      chemotherapies.&#xD;
&#xD;
      At present there are no phase II studies specifically examining medical treatment of&#xD;
      degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or&#xD;
      gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours,&#xD;
      although neither one has been shown to date to be superior to the other, nor have&#xD;
      decision-making criteria been clearly established. One phase II study published in 2009&#xD;
      proposed CAPOX as the reference treatment in light of the promising results obtained.&#xD;
      Patients suffering from ampullary cancer in this study however were combined with patients&#xD;
      who were suffering from small bowel adenocarcinoma.&#xD;
&#xD;
      In conclusion, a national cohort study is proposed to undertake a prospective analysis of the&#xD;
      outcome of all patients treated for ampullary adenocarcinoma (particularly survival without&#xD;
      recurrence and prognostic indicators for excised tumours and the duration of disease control&#xD;
      for tumours treated with palliative chemotherapy). The treatment methods will be left to the&#xD;
      free choice of the investigator and all patients may be included, regardless of stage of&#xD;
      their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will&#xD;
      be supplemented by a later biological study. In order to recruit sufficient patient numbers,&#xD;
      the study will be based on participation of the cooperative groups involved in the management&#xD;
      of digestive cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>The time interval between the date of diagnosis of the disease and date of death (all causes). Patients who are alive will be censured at the date of last news.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RECURRENCE FREE SURVIVAL</measure>
    <time_frame>3 years</time_frame>
    <description>The time interval between the date of diagnosis of the disease and the date of the recurrence or death (all causes). Patients who are alive without recurrence will be censured at the date of last news.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROGRESSION FREE SURVIVAL</measure>
    <time_frame>5 years</time_frame>
    <description>Time interval between the date of starting treatment and the date of first progression (local or remote, clinical or radiological) or death (all causes). Patients who are alive without progression will be censured at the date of last news. Radiological progression will be defined according to RECIST version 1.1 criteria.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">402</enrollment>
  <condition>Ampullary Adenocarcinoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>treatment for ampullary adenocarcinoma</intervention_name>
    <description>all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy).</description>
    <other_name>no other intervention name to add</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients treated for ampullary adenocarcinoma (particularly survival without recurrence&#xD;
        and prognostic indicators for excised tumours and the duration of disease control for&#xD;
        tumours treated with palliative chemotherapy).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years and older.&#xD;
&#xD;
          -  Histologically-proven adenocarcinoma of the ampulla of Vater which is operable or with&#xD;
             locoregional or metastatic recurrence after excision less than 6 months previously.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot be followed up regularly for psychological, social, family or&#xD;
             geographical reasons.&#xD;
&#xD;
          -  Non-ampullary tumours.&#xD;
&#xD;
          -  Non-adenocarcinomatous ampullary tumours.&#xD;
&#xD;
          -  Ampullary adenocarcinomas which are metastatic or locally advanced from the outset and&#xD;
             inoperable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien TAIEB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federation Francophone de Cancerologie Digestive</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julien TAIEB, Pr</last_name>
    <phone>01 56 09 35 56</phone>
    <phone_ext>+33</phone_ext>
    <email>jtaieb75@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ch D'Abbeville</name>
      <address>
        <city>Abbeville</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JOEL BUTEL</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Hotel Dieu</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NATHALIE BAIZE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Annecy Genevois</name>
      <address>
        <city>Annecy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ROMAN COMBES</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Cote Basque</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FRANCK AUDEMAR</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Saint Andre</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHABRUN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Polyclinique Bordeaux Nord Aquitaine</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BALHADERE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Champeau</name>
      <address>
        <city>Béziers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MICHAEL HUMMELSBERGER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DENIS PEZET</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopitaux Civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LAURIANNE PLASTARAS</last_name>
    </contact>
    <investigator>
      <last_name>CAMARA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>BREYSACHER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch - Sud Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SAMY LOUAFI</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Francois Mitterrand</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SYLVAIN MANFREDI</last_name>
    </contact>
    <investigator>
      <last_name>ANTOINE DROUILLARD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>JEAN LOUIS JOUVE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chd Vendee</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MORGAN AMIL</last_name>
    </contact>
    <investigator>
      <last_name>RAME</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>LALY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Le Kremlin Bicetre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane BENOIST</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>christophe MARIETTE</last_name>
    </contact>
    <investigator>
      <last_name>GUILLAUME PIESSEN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Dupuytren</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>STEPHANE BOUVIER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Nord Essonne</name>
      <address>
        <city>Longjumeau</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>YOUNES ZEKRI</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu La Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MARIELLE GUILLET</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hcl Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MUSTAPHA ADHAM</last_name>
    </contact>
    <investigator>
      <last_name>GRAILLOT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hcl Pierre Benite</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>OLIVIER GLEHEN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de La Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MARINE BARRAUD BLANC</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Joseph</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HERVE PERRIER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch de Meaux</name>
      <address>
        <city>Meaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHRISTOPHE LOCHER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH MACON</name>
      <address>
        <city>Mâcon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MARIE MARTIN BELLECOSTE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Caremeau</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CLAIRE PHILIPPE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chr Orleans</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BRAHIM OUAHRANI</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Avicenne</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>THOMAS APARICIO</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ROMAIN CORIAT</last_name>
    </contact>
    <investigator>
      <last_name>CROMBE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu La Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JEAN BAPTISTE BACHET</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ORIANNE COLUSSI</last_name>
    </contact>
    <investigator>
      <last_name>PERKINS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Saint Jean</name>
      <address>
        <city>Perpignan</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FAIZA KHEMISSA AKOUZ</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Hôpital de la Milétrie</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David TOUGERON</last_name>
      <email>david.tougeron@chu-poitiers.fr</email>
    </contact>
    <investigator>
      <last_name>David TOUGERON</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Cornouaille</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KARINE BIDEAU</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier BOUCHE</last_name>
      <email>obouche@chu-reims.fr</email>
    </contact>
    <investigator>
      <last_name>Olivier BOUCHE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Saint Malo</name>
      <address>
        <city>Saint-Malo</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ROMAIN DESGRIPPES</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CLINIQUE</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>YOUSSEF TAZI</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Bretagne Atlantique</name>
      <address>
        <city>Vannes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DENIS GRASSET</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800212
org study id: AMPULLOMA COHORT
nct id: NCT03800212
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive
      tumours. The only curative treatment is complete excision (surgical or endoscopic) of the
      lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference
      radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant
      treatment is still debated: in view of the aggressive nature of the disease and the high
      recurrence rate, it would appear appropriate to offer adjuvant treatment, although several
      studies have failed to find any benefit on survival with post-operative radio-chemotherapy,
      the most widely studied treatment at present, compared to excision alone. At present there
      are no phase II studies specifically examining medical treatment of degenerated, inoperable
      Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to
      the treatments used for intestinal, pancreatic or biliary tumours, although neither one has
      been shown to date to be superior to the other, nor have decision-making criteria been
      clearly established.In conclusion, a national cohort study is proposed to undertake a
      prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma
      (particularly survival without recurrence and prognostic indicators for excised tumours and
      the duration of disease control for tumours treated with palliative chemotherapy). The
      treatment methods will be left to the free choice of the investigator and all patients may be
      included, regardless of stage of their disease. In this study, freezing of tumour fragments
      is encouraged, as this cohort will be supplemented by a later biological study. In order to
      recruit sufficient patient numbers, the study will be based on participation of the
      cooperative groups involved in the management of digestive cancers.
A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive
      tumours. In terms of incidence, it is the 3rd most common biliary tract tumour after
      gallbladder cancer and common bile duct cancer. The incidence of ampullary adenocarcinoma is
      not well known although it is estimated to be around 0.49 per 100,000 people. The known risk
      factors are familial adenomatous polyposis (FAP) and Gardner's syndrome, HNPCC (Hereditary
      Non-Polyposis Colorectal Cancer) syndrome, Peutz-Jeghers syndrome, Crohn's disease and
      coeliac disease.

      Except in its highly localised forms, ampulla of Vater carcinoma carries a poor prognosis. It
      is a highly lymphophilic disease which commonly metastasises, particularly to the lymph nodes
      and liver. The prognosis is however considerably better than that of pancreatic
      adenocarcinoma. In one study which compared 71 ampullomas with 144 adenocarcinomas of
      pancreatic head, the 5-year survival was 60% for the ampullary carcinomas compared to 20% for
      pancreatic adenocarcinomas.

      More generally, the 5-year survival rate in the literature is between 40-60% and, depending
      on the study, 10-year survival is approximately 38% .

      The only curative treatment is complete excision (surgical or endoscopic) of the lesions
      which is possible in 80% of cases , with or without adjuvant treatment. The reference radical
      treatment is cephalic duodenopancreatectomy (CDP). The 5-year survival rate in cases of
      adenocarcinoma excised by CPD is in the region of 50%, rising to 60-70% if no lymph node
      invasion is present, compared to 30% when lymph nodes are invaded and median survival is
      approximately 4.5 years .

      The indication for adjuvant treatment is still debated: in view of the aggressive nature of
      the disease and the high recurrence rate, it would appear appropriate to offer adjuvant
      treatment, although several studies have failed to find any benefit on survival with
      post-operative radio-chemotherapy, the most widely studied treatment at present, compared to
      excision alone . There is only one single randomised study comparing these two forms of
      management, which shows no benefit in terms of 2 and 5-year survival, although only a small
      number of patients had an ampullary tumour in this study . The conclusions of several
      retrospective studies are more subtle, showing results in favour of adjuvant treatment in
      patients with lymph node disease or a large tumour (T3/T4) .

      Some groups have tested the merits of peroperative irradiation. It would appear that this
      technique does not improve survival, although data on this subject are extremely patchy .

      Administration of exclusive adjuvant chemotherapy has been examined in a single randomised
      study. In this phase III study (ESPAC 3), median overall survival of patients who received
      adjuvant chemotherapy with FUFOL Mayo for 6 months (n=101) or gemcitabine (n=98) was not
      significantly improved compared to survival in patients undergoing surgery and not receiving
      complementary treatment (57.1 versus 43 months, HR= 0.85, p=0.32). A subgroup analysis
      suggested that the benefit of chemotherapy could be greater in the subgroup of patients with
      RO resection (p= 0.057, 91% of cases).

      Mean survival in patients suffering inoperable tumours is between 9 and 20.4 months depending
      on the study .

      It should be noted however that most of these studies have included tumours other than
      ampullomas (particularly small bowel adenocarcinomas), making it more difficult to interpret
      these results, and also that many are old results dating from before the era of modern
      chemotherapies.

      At present there are no phase II studies specifically examining medical treatment of
      degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or
      gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours,
      although neither one has been shown to date to be superior to the other, nor have
      decision-making criteria been clearly established. One phase II study published in 2009
      proposed CAPOX as the reference treatment in light of the promising results obtained.
      Patients suffering from ampullary cancer in this study however were combined with patients
      who were suffering from small bowel adenocarcinoma.

      In conclusion, a national cohort study is proposed to undertake a prospective analysis of the
      outcome of all patients treated for ampullary adenocarcinoma (particularly survival without
      recurrence and prognostic indicators for excised tumours and the duration of disease control
      for tumours treated with palliative chemotherapy). The treatment methods will be left to the
      free choice of the investigator and all patients may be included, regardless of stage of
      their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will
      be supplemented by a later biological study. In order to recruit sufficient patient numbers,
      the study will be based on participation of the cooperative groups involved in the management
      of digestive cancers.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: 5 years
description: The time interval between the date of diagnosis of the disease and date of death (all causes). Patients who are alive will be censured at the date of last news.
measure: RECURRENCE FREE SURVIVAL
time frame: 3 years
description: The time interval between the date of diagnosis of the disease and the date of the recurrence or death (all causes). Patients who are alive without recurrence will be censured at the date of last news.
measure: PROGRESSION FREE SURVIVAL
time frame: 5 years
description: Time interval between the date of starting treatment and the date of first progression (local or remote, clinical or radiological) or death (all causes). Patients who are alive without progression will be censured at the date of last news. Radiological progression will be defined according to RECIST version 1.1 criteria.
intervention type: Drug
intervention name: treatment for ampullary adenocarcinoma
description: all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy).
other name: no other intervention name to add
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julien TAIEB
role: Principal Investigator
affiliation: Federation Francophone de Cancerologie Digestive
last name: Julien TAIEB, Pr
phone: 01 56 09 35 56
phone ext: +33
email: jtaieb75@gmail.com
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status: Recruiting
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country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: Undecided