<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/NCT01674309</url>
  </required_header>
  <id_info>
    <org_study_id>FFCD 1102</org_study_id>
    <nct_id>NCT01674309</nct_id>
  </id_info>
  <brief_title>First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis</brief_title>
  <official_title>Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,&#xD;
      with an objective response rate of about 70 %. This phase II is to investigate if this&#xD;
      systematic attack chemotherapy could control at the same time the rectal tumor and the&#xD;
      synchronous metastasis without compromising secondarily the tumor or the metastasis resection&#xD;
      or a radiochemotherapy administration.&#xD;
&#xD;
        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,&#xD;
           according to the RECIST criteria (version 1.1).&#xD;
&#xD;
        2. The secondary objectives are:&#xD;
&#xD;
             -  safety of the treament,&#xD;
&#xD;
             -  rate of local failure and local complication (occlusion, important bleedings,&#xD;
                resistant pains with morphinic treatment, perforation),&#xD;
&#xD;
             -  survival without local failure (radiological or clinical progression of the rectal&#xD;
                cancer or local complication),&#xD;
&#xD;
             -  rectal tumor response rate (CT scan, MRI and endocopy),&#xD;
&#xD;
             -  metastasis response rate,&#xD;
&#xD;
             -  disease free survival after complete resection (of primitive tumor and metastases),&#xD;
&#xD;
             -  progression free survival (local or distal),&#xD;
&#xD;
             -  overall survival, quality of life (QLQ-C30 + CR 29).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,&#xD;
      with an objective response rate of about 70 %. This phase II is to investigate if this&#xD;
      systematic attack chemotherapy could control at the same time the rectal tumor and the&#xD;
      synchronous metastasis without compromising secondarily the tumor or the metastasis resection&#xD;
      or a radiochemotherapy administration.&#xD;
&#xD;
        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,&#xD;
           according to the RECIST criteria (version 1.1).&#xD;
&#xD;
        2. The secondary objectives are:&#xD;
&#xD;
             -  safety of the treament,&#xD;
&#xD;
             -  rate of local failure and local complication (occlusion, important bleedings,&#xD;
                resistant pains with morphinic treatment, perforation),&#xD;
&#xD;
             -  survival without local failure (radiological or clinical progression of the rectal&#xD;
                cancer or local complication),&#xD;
&#xD;
             -  rectal tumor response rate (CT scan, MRI and endocopy),&#xD;
&#xD;
             -  metastasis response rate,&#xD;
&#xD;
             -  disease free survival after complete resection (of primitive tumor and metastases),&#xD;
&#xD;
             -  progression free survival (local or distal),&#xD;
&#xD;
             -  overall survival, quality of life (QLQ-C30 + CR 29).&#xD;
&#xD;
        3. Inclusion and non inclusion criteria&#xD;
&#xD;
        4. Treatment&#xD;
&#xD;
        5. Follow up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor control rate of the primary tumor and metastasis</measure>
    <time_frame>4 months</time_frame>
    <description>The tumor control rate of the primary site and metastasis is defined as Complete response or Partial response or stability according to RECIST 1.1 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity of the treatment</measure>
    <time_frame>Up to 4 months after Last Patient First Visit</time_frame>
    <description>Number of patients presenting the main toxicities during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)</measure>
    <time_frame>4 months</time_frame>
    <description>The rate is defined as the clinical progression or a radiological progression of the rectum cancer or a local complication due to the treatment or due to the progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival without local failure (radiological or clinical progression of the rectal cancer or local complication)</measure>
    <time_frame>Up to 4 months after Last Patient First Visit</time_frame>
    <description>The survival time is defined as the time between the patient's inclusion and the time of the local failure or patient's death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rectal tumor response rate (CT scan, MRI and endocopy)</measure>
    <time_frame>4 months</time_frame>
    <description>The rectal tumor response rate is the Complete response or the Partial response of the rectal tumor using RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metastasis response rate</measure>
    <time_frame>4 months</time_frame>
    <description>The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Adenocarcinoma of Rectum</condition>
  <arm_group>
    <arm_group_label>single arm study/ non randomized trial</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FOLFORINOX</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFORINOX</intervention_name>
    <description>INTRAVENOUS administration</description>
    <arm_group_label>single arm study/ non randomized trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven adenocarcinoma of the rectum, the lower pole less than 15 cm&#xD;
             from the anal verge&#xD;
&#xD;
          -  Patient should not have receive any treatment for cancer&#xD;
&#xD;
          -  Synchronous metastases with unresectable hepatic and/or lung localization or uncertain&#xD;
             resectability (potentially resectable)&#xD;
&#xD;
          -  Measurable lesions by RECIST 1.1 (metastasis and primary cancer of the rectum)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  WHO ≤ 2&#xD;
&#xD;
          -  ANC ≥ 1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, creatinine clearance ≥ 60 mL/min&#xD;
&#xD;
          -  Hemoglobin ≥ 10 g /dL&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rectal Cancer in occlusion requiring surgery or a prosthesis in emergency&#xD;
&#xD;
          -  Rectal bleeding severe and active&#xD;
&#xD;
          -  Prior pelvic irradiation&#xD;
&#xD;
          -  History of cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix&#xD;
             treated curatively and other cancers treated curatively if they do not relapse over 3&#xD;
             years,&#xD;
&#xD;
          -  Hepatic impairment (total bilirubin&gt; 1.5 x upper limit of normal (ULN) and serum&#xD;
             albumin &lt;25g / L); known Gilbert's disease&#xD;
&#xD;
          -  Uncontrolled severe infection,&#xD;
&#xD;
          -  Severe pain (VAS&gt; 5/10) uncontrollable by opioid therapy&#xD;
&#xD;
          -  Symptomatic sensorimotor peripheral neuropathy&#xD;
&#xD;
          -  Pregnant or lactating patients or patient of both sexes with childbearing potential&#xD;
             and not using adequate contraception method&#xD;
&#xD;
          -  Patient receiving or having received an experimental therapy within 4 weeks prior to&#xD;
             enter into the study or participating in another clinical study of other experimental&#xD;
             drugs&#xD;
&#xD;
          -  Known hypersensitivity to any component of the treatment&#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>Jean-Baptiste BACHET, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de La Pitié Salpetrière - APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Beauvais</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avicennes</name>
      <address>
        <city>Bobigny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU - Ht Lévêque</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Béziers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Estaing</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colmar Ch</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre G.F. Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique</name>
      <address>
        <city>Francheville</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche Sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Victor Hugo</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU - Hôpital Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ipc - Cac</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Layne</name>
      <address>
        <city>Mont de Marsan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Cahterine de Sienne</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique le Languedoc</name>
      <address>
        <city>Narbonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Georges Menon</name>
      <address>
        <city>Niort</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR - Gasto</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP - HP - Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Pau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Perpignan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Le Foll</name>
      <address>
        <city>Saint Brieuc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Armoricaine</name>
      <address>
        <city>Saint Brieuc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Côte Basque Sud</name>
      <address>
        <city>Saint Jean De Luz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Robert Morlevat</name>
      <address>
        <city>Semur en Auxois</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAC</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique de l'Ormeau</name>
      <address>
        <city>Tarbes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux du Leman</name>
      <address>
        <city>Thonon Les Bains</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Jean du Languedoc</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Trousseau</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Bachet JB, Lucidarme O, Levache CB, Barbier E, Raoul JL, Lecomte T, Desauw C, Brocard F, Pernot S, Breysacher G, Lagasse JP, Di Fiore F, Etienne PL, Dupuis OJM, Aleba A, Lepage C, Taieb J; for FFCD 1102 investigators. FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial. Eur J Cancer. 2018 Nov;104:108-116. doi: 10.1016/j.ejca.2018.09.006. Epub 2018 Oct 18.</citation>
    <PMID>30343254</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>April 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</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>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01674309
org study id: FFCD 1102
nct id: NCT01674309
lead sponsor: 
has dmc: Yes
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,
      with an objective response rate of about 70 %. This phase II is to investigate if this
      systematic attack chemotherapy could control at the same time the rectal tumor and the
      synchronous metastasis without compromising secondarily the tumor or the metastasis resection
      or a radiochemotherapy administration.

        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,
           according to the RECIST criteria (version 1.1).

        2. The secondary objectives are:

             -  safety of the treament,

             -  rate of local failure and local complication (occlusion, important bleedings,
                resistant pains with morphinic treatment, perforation),

             -  survival without local failure (radiological or clinical progression of the rectal
                cancer or local complication),

             -  rectal tumor response rate (CT scan, MRI and endocopy),

             -  metastasis response rate,

             -  disease free survival after complete resection (of primitive tumor and metastases),

             -  progression free survival (local or distal),

             -  overall survival, quality of life (QLQ-C30 + CR 29).
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,
      with an objective response rate of about 70 %. This phase II is to investigate if this
      systematic attack chemotherapy could control at the same time the rectal tumor and the
      synchronous metastasis without compromising secondarily the tumor or the metastasis resection
      or a radiochemotherapy administration.

        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,
           according to the RECIST criteria (version 1.1).

        2. The secondary objectives are:

             -  safety of the treament,

             -  rate of local failure and local complication (occlusion, important bleedings,
                resistant pains with morphinic treatment, perforation),

             -  survival without local failure (radiological or clinical progression of the rectal
                cancer or local complication),

             -  rectal tumor response rate (CT scan, MRI and endocopy),

             -  metastasis response rate,

             -  disease free survival after complete resection (of primitive tumor and metastases),

             -  progression free survival (local or distal),

             -  overall survival, quality of life (QLQ-C30 + CR 29).

        3. Inclusion and non inclusion criteria

        4. Treatment

        5. Follow up
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor control rate of the primary tumor and metastasis
time frame: 4 months
description: The tumor control rate of the primary site and metastasis is defined as Complete response or Partial response or stability according to RECIST 1.1 criteria
measure: Toxicity of the treatment
time frame: Up to 4 months after Last Patient First Visit
description: Number of patients presenting the main toxicities during the study
measure: rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)
time frame: 4 months
description: The rate is defined as the clinical progression or a radiological progression of the rectum cancer or a local complication due to the treatment or due to the progression
measure: survival without local failure (radiological or clinical progression of the rectal cancer or local complication)
time frame: Up to 4 months after Last Patient First Visit
description: The survival time is defined as the time between the patient's inclusion and the time of the local failure or patient's death
measure: rectal tumor response rate (CT scan, MRI and endocopy)
time frame: 4 months
description: The rectal tumor response rate is the Complete response or the Partial response of the rectal tumor using RECIST 1.1 criteria
measure: metastasis response rate
time frame: 4 months
description: The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria
arm group label: single arm study/ non randomized trial
arm group type: Other
description: FOLFORINOX
intervention type: Drug
intervention name: FOLFORINOX
description: INTRAVENOUS administration
arm group label: single arm study/ non randomized trial
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Baptiste BACHET, Dr
role: Principal Investigator
affiliation: CHU de La Pitié Salpetrière - APHP
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Bachet JB, Lucidarme O, Levache CB, Barbier E, Raoul JL, Lecomte T, Desauw C, Brocard F, Pernot S, Breysacher G, Lagasse JP, Di Fiore F, Etienne PL, Dupuis OJM, Aleba A, Lepage C, Taieb J; for FFCD 1102 investigators. FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial. Eur J Cancer. 2018 Nov;104:108-116. doi: 10.1016/j.ejca.2018.09.006. Epub 2018 Oct 18.
PMID: 30343254
responsible party type: Sponsor
mesh term: Rectal Neoplasms