<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/NCT03042169</url>
  </required_header>
  <id_info>
    <org_study_id>2015_07</org_study_id>
    <secondary_id>2016-A01265-46</secondary_id>
    <nct_id>NCT03042169</nct_id>
  </id_info>
  <brief_title>Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer</brief_title>
  <acronym>SURGIGAST</acronym>
  <official_title>Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer - a Multicenter, Prospective, Open-labeled, Two-armed, Randomized, Controlled Phase III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Surgical resection of the primary tumour and treatment of the metastatic site in&#xD;
      oligometastatic stage IV metastatic gastric adenocarcinoma enhances survival and improves&#xD;
      quality of life with acceptable postoperative morbidity and mortality in a selected group of&#xD;
      operable patients with only one metastatic site that does not progress under chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 25, 2021</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ C30</measure>
    <time_frame>Every 3 months during 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QLQ STO 22 questionnaires</measure>
    <time_frame>Every 3 months during 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>from randomisation to the date of documented progression according to RECIST or death whatever the cause,assessed up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgery related postoperative morbidity-mortality</measure>
    <time_frame>within 30 days and 90 days</time_frame>
    <description>grade III, IV and V and complications according to the Dindo-Clavien classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific complications related to treatment of the metastatic site</measure>
    <time_frame>within 30 days and 90 days post-treatment</time_frame>
    <description>grade III, IV and V complications according to the Dindo-Clavien classification for surgical treatment strategy and grade III, IV and V adverse reactions according to the NCI-CTCAE v5.0 for other treatment strategies (i.e. HIPEC, radiofrequency, microwave and radiotherapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0</measure>
    <time_frame>Every 3 months during 2 years]</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall cumulative duration of hospitalisation</measure>
    <time_frame>throughout the duration of the study, during 2 years</time_frame>
    <description>calculated in days from randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of interventional palliative procedures per patient</measure>
    <time_frame>throughout the duration of the study, during 2 years</time_frame>
    <description>mean per patient from randomization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">424</enrollment>
  <condition>Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>continuation of chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to arm A will continue to receive the same chemotherapy regimen they received before randomization. Chemotherapy should be restarted between D1 and D30 after randomization.&#xD;
In case of poor tolerance to the induction chemotherapy, alternative chemotherapy regimen might be discussed, according to local standards and national guidelines (www.tncd.org).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to arm B will undergo gastrectomy (subtotal or total according to the location of the primary tumour) between D1 and D30 after randomization.&#xD;
Subtotal gastrectomy is recommended if it allows a complete resection of the primary tumour to limit postoperative morbidity in such metastatic situations, based on the results of REGATTA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preoperative Chemotherapy</intervention_name>
    <description>Standard chemotherapy regiments according to risk of recurrence</description>
    <arm_group_label>continuation of chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.</description>
    <arm_group_label>surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy</arm_group_label>
    <other_name>surgical removal of the primary tumour followed by chemotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Postoperative chemotherapy</intervention_name>
    <description>Chemotherapy should be restarted between D1 and D30 post-randomization</description>
    <arm_group_label>continuation of chemotherapy</arm_group_label>
    <arm_group_label>surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary diagnosis of UICC stage IV gastric adenocarcinoma with histological proof of&#xD;
             the primary tumour (with HER2 status, PCC histology and MMR status available and SRC&#xD;
             histology available on anatomo-pathology reports)&#xD;
&#xD;
          2. Without any form of previous treatment (surgery and / or chemotherapy and / or&#xD;
             radiotherapy) for this diagnosis other than local endoscopic treatment. Note : 3.&#xD;
             pPatients having received first line chemotherapy for at least 2 months and completing&#xD;
             inclusion/exclusion criteria can be included in the study at V2&#xD;
&#xD;
          3. Locally resectable primary tumour and oligometastatic lesion accessible to surgical&#xD;
             resection or local ablation procedure&#xD;
&#xD;
          4. Oligometastatic lesion : Retro-Peritoneal Lymph Node Metastases (RPLM) and/or another&#xD;
             metastatic lesion on only one organ (solid organ, lymph node or limited localised&#xD;
             peritoneal carcinomatosis with PCI &lt; 7) according to the following non-exhaustive list&#xD;
             of definitions:&#xD;
&#xD;
               1. RPLM: para-aortal, intra-aorto-caval, para-pancreatic or mesenteric lymph&#xD;
                  node(s). Note: in duodenum invading gastric cancer, retro-pancreatic nodes are&#xD;
                  not regarded as metastatic sites&#xD;
&#xD;
               2. Other acceptable limited metastatic lesions:&#xD;
&#xD;
                    -  Localized potentially operable peritoneal carcinomatosis: PCI &lt; 7 including&#xD;
                       uni or bilateral Krukenberg tumors (ovarian metastases)&#xD;
&#xD;
                    -  Liver: maximum of 5 metastatic lesions that are potentially resectable&#xD;
&#xD;
                    -  Lung: unilateral involvement, potentially resectable&#xD;
&#xD;
                    -  Uni- or bilateral adrenal gland metastases&#xD;
&#xD;
                    -  Extra-abdominal lymph node metastases such as supraclavicular or cervical&#xD;
                       lymph node involvement&#xD;
&#xD;
                    -  Localized bone involvement (defined as being within one radiation field)&#xD;
                       Notes: 1. Patients with more than one metastatic site in only one organ are&#xD;
                       eligible. 2. In case of doubt for considering whether a metastatic site is&#xD;
                       limited or not, please submit the case with relevant anonymised information&#xD;
                       to the medical coordinator of the study for approval. 6. Only one solid&#xD;
                       organ metastatic site (hepatic, lung, adrenal gland, bone, brain...).&#xD;
                       Patients with more than one metastatic lesion in only one organ are eligible&#xD;
&#xD;
          5. ECOG performance status 0 or 1&#xD;
&#xD;
          6. Man or women aged ≥ 18 years and ≤ 80 years&#xD;
&#xD;
          7. For surgery and/or chemotherapy, adequate cardiac, respiratory, bone marrow, renal and&#xD;
             liver functions according to usual practices standards&#xD;
&#xD;
          8. Ability to understand and complete quality of life questionnaires (EORTC QLQ C30 and&#xD;
             QLQ STO 22)&#xD;
&#xD;
          9. Negative pregnancy test (urine or serum) performed prior to start the study in for&#xD;
             females of childbearing potential with reproductive potential&#xD;
&#xD;
         10. Male and female patients of child-bearing reproductive potential must agree to us an&#xD;
             effective method of contraception approved by the investigator during the study and&#xD;
             for a minimum of 6 months after the end of study treatment&#xD;
&#xD;
         11. Patient covered by a government Health Insurance&#xD;
&#xD;
         12. Patient who provides a signed written Inform Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other histological subtype than adenocarcinoma&#xD;
&#xD;
          2. ECOG performance status ≥ 2 2,3 or 4&#xD;
&#xD;
          3. Diffuse peritoneal carcinomatosis (PCI ≥ 7) or significant ascites&#xD;
&#xD;
          4. Metastatic disease involving more than one solid organ metastatic site&#xD;
&#xD;
          5. Primary tumor irresectability and/or metastatic lesion not accessible for resection or&#xD;
             local ablation procedure or need for multi-visceral resection with expected high&#xD;
             complication rate&#xD;
&#xD;
          6. Contraindication to chemotherapy or surgery according to the multidisciplinary team&#xD;
             decision&#xD;
&#xD;
          7. Second uncontrolled malignant tumour&#xD;
&#xD;
          8. Proximal (junctionnal) tumour growth across the Z-line requiring additional trans&#xD;
             thoracic oesophageal resectionµ&#xD;
&#xD;
          9. Emergency surgery due to bleeding or perforation&#xD;
&#xD;
         10. Age &gt; 80 years&#xD;
&#xD;
         11. Weight loss ≥ 20% persisting despite appropriate nutritional assistance&#xD;
&#xD;
         12. Severe comorbid conditions that may jeopardize short term outcomes (e.g. cardiac,&#xD;
             respiratory, bone marrow, renal or liver insufficiency...)&#xD;
&#xD;
         13. Dihydropyrimidine dehydrogenase Deficiency (DPD)&#xD;
&#xD;
         14. Women who are pregnant or breastfeeding&#xD;
&#xD;
         15. Patients in emergency situations&#xD;
&#xD;
         16. Patients kept in detention and/or under legal protection under psychiatric care and/or&#xD;
             interned in a social or psychiatric institution&#xD;
&#xD;
         17. Adult patient under legal protection or in the incapacity to express his/her consent&#xD;
&#xD;
         18. Patient not covered by a health insurance system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume Piessen, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guillaume Piessen, MD,PhD</last_name>
    <phone>0320445962</phone>
    <phone_ext>+33</phone_ext>
    <email>guillaume.piessen@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ico - Site Gauducheau - St Herblain</name>
      <address>
        <city>Saint-Herblain</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stage IV gastric cancer</keyword>
  <keyword>palliative surgery</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>survival</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03042169
org study id: 2015_07
secondary id: 2016-A01265-46
nct id: NCT03042169
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical resection of the primary tumour and treatment of the metastatic site in
      oligometastatic stage IV metastatic gastric adenocarcinoma enhances survival and improves
      quality of life with acceptable postoperative morbidity and mortality in a selected group of
      operable patients with only one metastatic site that does not progress under chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall survival
time frame: Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years
measure: EORTC QLQ C30
time frame: Every 3 months during 2 years
measure: QLQ STO 22 questionnaires
time frame: Every 3 months during 2 years
measure: Progression free survival
time frame: from randomisation to the date of documented progression according to RECIST or death whatever the cause,assessed up to 2 years
measure: Surgery related postoperative morbidity-mortality
time frame: within 30 days and 90 days
description: grade III, IV and V and complications according to the Dindo-Clavien classification
measure: Specific complications related to treatment of the metastatic site
time frame: within 30 days and 90 days post-treatment
description: grade III, IV and V complications according to the Dindo-Clavien classification for surgical treatment strategy and grade III, IV and V adverse reactions according to the NCI-CTCAE v5.0 for other treatment strategies (i.e. HIPEC, radiofrequency, microwave and radiotherapy).
measure: Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0
time frame: Every 3 months during 2 years]
measure: Overall cumulative duration of hospitalisation
time frame: throughout the duration of the study, during 2 years
description: calculated in days from randomization
measure: Number of interventional palliative procedures per patient
time frame: throughout the duration of the study, during 2 years
description: mean per patient from randomization
arm group label: continuation of chemotherapy
arm group type: Active Comparator
description: Patients assigned to arm A will continue to receive the same chemotherapy regimen they received before randomization. Chemotherapy should be restarted between D1 and D30 after randomization.
In case of poor tolerance to the induction chemotherapy, alternative chemotherapy regimen might be discussed, according to local standards and national guidelines (www.tncd.org).
arm group label: surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy
arm group type: Experimental
description: Patients assigned to arm B will undergo gastrectomy (subtotal or total according to the location of the primary tumour) between D1 and D30 after randomization.
Subtotal gastrectomy is recommended if it allows a complete resection of the primary tumour to limit postoperative morbidity in such metastatic situations, based on the results of REGATTA
intervention type: Drug
intervention name: Preoperative Chemotherapy
description: Standard chemotherapy regiments according to risk of recurrence
arm group label: continuation of chemotherapy
intervention type: Procedure
intervention name: Surgery
description: the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.
arm group label: surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy
other name: surgical removal of the primary tumour followed by chemotherapy
intervention type: Drug
intervention name: Postoperative chemotherapy
description: Chemotherapy should be restarted between D1 and D30 post-randomization
arm group label: continuation of chemotherapy
arm group label: surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guillaume Piessen, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Guillaume Piessen, MD,PhD
phone: 0320445962
phone ext: +33
email: guillaume.piessen@chru-lille.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Stomach Neoplasms
sharing ipd: No