TerminatedPhase 3

Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer

Stopped: default inclusion

France6 participantsStarted 2021-08-25

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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)

Exclusion criteria

✕. 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)

What they're measuring

Overall survival

Timeframe: Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years

Trial details

NCT IDNCT03042169

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-28

View on ClinicalTrials.gov More Gastric Adenocarcinoma trials