Gastric Adenocarcinoma
Conditions
Keywords
Stage IV gastric cancer, palliative surgery, chemotherapy, survival, quality of life
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.
Interventions
Standard chemotherapy regiments according to risk of recurrence
PROCEDURESurgery
the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.
Chemotherapy should be restarted between D1 and D30 post-randomization
Sponsors
National Cancer Institute, France
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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) 2. 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | grade III, IV and V and complications according to the Dindo-Clavien classification |
| EORTC QLQ C30 | Every 3 months during 2 years | — |
| 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 | throughout the duration of the study, during 2 years | calculated in days from randomization |
| Number of interventional palliative procedures per patient | throughout the duration of the study, during 2 years | mean per patient from randomization |
| Specific complications related to treatment of the metastatic site | within 30 days and 90 days post-treatment | 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). |
Countries
France
Outcome results
None listed