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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01265-46 | Other Identifier | ID-RCB number, ANSM |
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default inclusion
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuation of chemotherapy | Active Comparator | 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). |
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| surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Chemotherapy | Drug | Standard chemotherapy regiments according to risk of recurrence |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ C30 | Every 3 months during 2 years | |
| QLQ STO 22 questionnaires | Every 3 months during 2 years | |
| Progression free survival |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Piessen, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ico - Site Gauducheau - St Herblain | Saint-Herblain | France |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Procedure | the surgical treatment will undergo gastrectomy between D1 and D30 after randomization. |
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| Postoperative chemotherapy | Drug | Chemotherapy should be restarted between D1 and D30 post-randomization |
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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 |
| Surgery related postoperative morbidity-mortality | grade III, IV and V and complications according to the Dindo-Clavien classification | within 30 days and 90 days |
| Specific complications related to treatment of the metastatic site | 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). | within 30 days and 90 days post-treatment |
| Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0 | Every 3 months during 2 years] |
| Overall cumulative duration of hospitalisation | calculated in days from randomization | throughout the duration of the study, during 2 years |
| Number of interventional palliative procedures per patient | mean per patient from randomization | throughout the duration of the study, during 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |