Status and phase
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About
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.
Enrollment
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Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
424 participants in 2 patient groups
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Central trial contact
Guillaume Piessen, MD,PhD
Data sourced from clinicaltrials.gov
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