- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03042169
Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer (SURGIGAST)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Saint-Herblain, France
- Recruiting
- Ico - Site Gauducheau - St Herblain
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary diagnosis of UICC stage IV gastric adenocarcinoma with histological proof of the primary tumour (with HER2 status, PCC histology and MMR status available and SRC histology available on anatomo-pathology reports)
- Without any form of previous treatment (surgery and / or chemotherapy and / or radiotherapy) for this diagnosis other than local endoscopic treatment. Note : 3. pPatients having received first line chemotherapy for at least 2 months and completing inclusion/exclusion criteria can be included in the study at V2
- Locally resectable primary tumour and oligometastatic lesion accessible to surgical resection or local ablation procedure
Oligometastatic lesion : Retro-Peritoneal Lymph Node Metastases (RPLM) and/or another metastatic lesion on only one organ (solid organ, lymph node or limited localised peritoneal carcinomatosis with PCI < 7) according to the following non-exhaustive list of definitions:
- RPLM: para-aortal, intra-aorto-caval, para-pancreatic or mesenteric lymph node(s). Note: in duodenum invading gastric cancer, retro-pancreatic nodes are not regarded as metastatic sites
Other acceptable limited metastatic lesions:
- Localized potentially operable peritoneal carcinomatosis: PCI < 7 including uni or bilateral Krukenberg tumors (ovarian metastases)
- Liver: maximum of 5 metastatic lesions that are potentially resectable
- Lung: unilateral involvement, potentially resectable
- Uni- or bilateral adrenal gland metastases
- Extra-abdominal lymph node metastases such as supraclavicular or cervical lymph node involvement
- Localized bone involvement (defined as being within one radiation field) Notes: 1. Patients with more than one metastatic site in only one organ are eligible. 2. In case of doubt for considering whether a metastatic site is limited or not, please submit the case with relevant anonymised information to the medical coordinator of the study for approval. 6. Only one solid organ metastatic site (hepatic, lung, adrenal gland, bone, brain...). Patients with more than one metastatic lesion in only one organ are eligible
- ECOG performance status 0 or 1
- Man or women aged ≥ 18 years and ≤ 80 years
- For surgery and/or chemotherapy, adequate cardiac, respiratory, bone marrow, renal and liver functions according to usual practices standards
- Ability to understand and complete quality of life questionnaires (EORTC QLQ C30 and QLQ STO 22)
- Negative pregnancy test (urine or serum) performed prior to start the study in for females of childbearing potential with reproductive potential
- Male and female patients of child-bearing reproductive potential must agree to us an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after the end of study treatment
- Patient covered by a government Health Insurance
- Patient who provides a signed written Inform Consent
Exclusion Criteria:
- Other histological subtype than adenocarcinoma
- ECOG performance status ≥ 2 2,3 or 4
- Diffuse peritoneal carcinomatosis (PCI ≥ 7) or significant ascites
- Metastatic disease involving more than one solid organ metastatic site
- Primary tumor irresectability and/or metastatic lesion not accessible for resection or local ablation procedure or need for multi-visceral resection with expected high complication rate
- Contraindication to chemotherapy or surgery according to the multidisciplinary team decision
- Second uncontrolled malignant tumour
- Proximal (junctionnal) tumour growth across the Z-line requiring additional trans thoracic oesophageal resectionµ
- Emergency surgery due to bleeding or perforation
- Age > 80 years
- Weight loss ≥ 20% persisting despite appropriate nutritional assistance
- Severe comorbid conditions that may jeopardize short term outcomes (e.g. cardiac, respiratory, bone marrow, renal or liver insufficiency...)
- Dihydropyrimidine dehydrogenase Deficiency (DPD)
- Women who are pregnant or breastfeeding
- Patients in emergency situations
- Patients kept in detention and/or under legal protection under psychiatric care and/or interned in a social or psychiatric institution
- Adult patient under legal protection or in the incapacity to express his/her consent
- Patient not covered by a health insurance system
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: continuation of chemotherapy
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). |
Standard chemotherapy regiments according to risk of recurrence
Chemotherapy should be restarted between D1 and D30 post-randomization
|
EXPERIMENTAL: surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy
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 |
Chemotherapy should be restarted between D1 and D30 post-randomization
the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years
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Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EORTC QLQ C30
Time Frame: Every 3 months during 2 years
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Every 3 months during 2 years
|
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QLQ STO 22 questionnaires
Time Frame: Every 3 months during 2 years
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Every 3 months during 2 years
|
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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
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from randomisation to the date of documented progression according to RECIST or death whatever the cause,assessed up to 2 years
|
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Surgery related postoperative morbidity-mortality
Time Frame: within 30 days and 90 days
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grade III, IV and V and complications according to the Dindo-Clavien classification
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within 30 days and 90 days
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Specific complications related to treatment of the metastatic site
Time Frame: within 30 days and 90 days post-treatment
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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).
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within 30 days and 90 days post-treatment
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Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0
Time Frame: Every 3 months during 2 years]
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Every 3 months during 2 years]
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Overall cumulative duration of hospitalisation
Time Frame: throughout the duration of the study, during 2 years
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calculated in days from randomization
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throughout the duration of the study, during 2 years
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Number of interventional palliative procedures per patient
Time Frame: throughout the duration of the study, during 2 years
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mean per patient from randomization
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throughout the duration of the study, during 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015_07
- 2016-A01265-46 (OTHER: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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