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

NCT03042169 | Terminated Phase 3

• 2 other identifiers: 2015_072016-A01265-46
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Adenocarcinoma

Keywords

Stage IV gastric cancer; palliative surgery; chemotherapy; survival; quality of life

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

Secondary Outcomes (8)

• EORTC QLQ C30

  Every 3 months during 2 years

• QLQ STO 22 questionnaires

  Every 3 months during 2 years

• Progression free survival

  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

  within 30 days and 90 days

• Specific complications related to treatment of the metastatic site

  within 30 days and 90 days post-treatment

Study Arms (2)

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).

Drug: Preoperative Chemotherapy; Drug: Postoperative chemotherapy

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

Procedure: Surgery; Drug: Postoperative chemotherapy

Interventions

Preoperative Chemotherapy DRUG

Standard chemotherapy regiments according to risk of recurrence

continuation of chemotherapy

Surgery PROCEDURE

the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.

Also known as: surgical removal of the primary tumour followed by chemotherapy

surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy

Postoperative chemotherapy DRUG

Chemotherapy should be restarted between D1 and D30 post-randomization

continuation of chemotherapy; surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Ico - Site Gauducheau - St Herblain

Saint-Herblain, France

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Guillaume Piessen, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 3, 2017
• Study Start: August 25, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)