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

NCT ID: NCT03042169

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2024-08-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Preoperative Chemotherapy

Intervention Type: DRUG

Standard chemotherapy regiments according to risk of recurrence

Postoperative chemotherapy

Intervention Type: DRUG

Chemotherapy should be restarted between D1 and D30 post-randomization

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

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

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

Postoperative chemotherapy

Intervention Type: DRUG

Chemotherapy should be restarted between D1 and D30 post-randomization

Interventions

Preoperative Chemotherapy

Standard chemotherapy regiments according to risk of recurrence

Intervention Type: DRUG

Surgery

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

Intervention Type: PROCEDURE

Postoperative chemotherapy

Chemotherapy should be restarted between D1 and D30 post-randomization

Intervention Type: DRUG

Other Intervention Names

surgical removal of the primary tumour followed by chemotherapy

Eligibility Criteria

Inclusion Criteria

1. 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

3. Locally resectable primary tumour and oligometastatic lesion accessible to surgical resection or local ablation procedure

4. 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:

1. 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

2. 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

5. ECOG performance status 0 or 1

6. Man or women aged ≥ 18 years and ≤ 80 years

7. For surgery and/or chemotherapy, adequate cardiac, respiratory, bone marrow, renal and liver functions according to usual practices standards

8. Ability to understand and complete quality of life questionnaires (EORTC QLQ C30 and QLQ STO 22)

9. Negative pregnancy test (urine or serum) performed prior to start the study in for females of childbearing potential with reproductive potential

10. 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

11. Patient covered by a government Health Insurance

12. Patient who provides a signed written Inform Consent

1. Other histological subtype than adenocarcinoma

2. ECOG performance status ≥ 2 2,3 or 4

3. Diffuse peritoneal carcinomatosis (PCI ≥ 7) or significant ascites

4. Metastatic disease involving more than one solid organ metastatic site

5. 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

6. Contraindication to chemotherapy or surgery according to the multidisciplinary team decision

7. Second uncontrolled malignant tumour

8. Proximal (junctionnal) tumour growth across the Z-line requiring additional trans thoracic oesophageal resectionµ

9. Emergency surgery due to bleeding or perforation

10. Age > 80 years

11. Weight loss ≥ 20% persisting despite appropriate nutritional assistance

12. Severe comorbid conditions that may jeopardize short term outcomes (e.g. cardiac, respiratory, bone marrow, renal or liver insufficiency...)

13. Dihydropyrimidine dehydrogenase Deficiency (DPD)

14. Women who are pregnant or breastfeeding

15. Patients in emergency situations

16. Patients kept in detention and/or under legal protection under psychiatric care and/or interned in a social or psychiatric institution

17. Adult patient under legal protection or in the incapacity to express his/her consent

18. Patient not covered by a health insurance system

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Piessen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Ico - Site Gauducheau - St Herblain

Saint-Herblain, , France

Countries

France

Other Identifiers

2016-A01265-46

Identifier Type: OTHER

Identifier Source: secondary_id

2015_07

Identifier Type: -

Identifier Source: org_study_id