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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
Standard chemotherapy regiments according to risk of recurrence
the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.
Chemotherapy should be restarted between D1 and D30 post-randomization
Ico - Site Gauducheau - St Herblain
Saint-Herblain, France
Overall survival
Time frame: Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years
EORTC QLQ C30
Time frame: Every 3 months during 2 years
QLQ STO 22 questionnaires
Time frame: Every 3 months during 2 years
Progression free survival
Time frame: 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
grade III, IV and V and complications according to the Dindo-Clavien classification
Time frame: within 30 days and 90 days
Specific complications related to treatment of the metastatic site
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).
Time frame: within 30 days and 90 days post-treatment
Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0
Time frame: Every 3 months during 2 years]
Overall cumulative duration of hospitalisation
calculated in days from randomization
Time frame: throughout the duration of the study, during 2 years
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Number of interventional palliative procedures per patient
mean per patient from randomization
Time frame: throughout the duration of the study, during 2 years