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

Gastric Adenocarcinoma Clinical Trial

— SURGIGAST  

Official title:

Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer - a Multicenter, Prospective, Open-labeled, Two-armed, Randomized, Controlled Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03042169
• Other study ID #: 2015_07
• Secondary ID: 2016-A01265-46
• Status: Recruiting
• Phase: Phase 3
• Start date: August 25, 2021
• Est. completion date: February 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Guillaume Piessen, MD,PhD
• Phone: 0320445962
• Email: guillaume.piessen[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Gastric Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Preoperative Chemotherapy
Standard chemotherapy regiments according to risk of recurrence

Procedure:
• Surgery
the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.

Drug:
• Postoperative chemotherapy
Chemotherapy should be restarted between D1 and D30 post-randomization

Locations

Country	Name	City	State
France	Ico - Site Gauducheau - St Herblain	Saint-Herblain

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years
Secondary	EORTC QLQ C30		Every 3 months during 2 years
Secondary	QLQ STO 22 questionnaires		Every 3 months during 2 years
Secondary	Progression free survival		from randomisation to the date of documented progression according to RECIST or death whatever the cause,assessed up to 2 years
Secondary	Surgery related postoperative morbidity-mortality	grade III, IV and V and complications according to the Dindo-Clavien classification	within 30 days and 90 days
Secondary	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).	within 30 days and 90 days post-treatment
Secondary	Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0		Every 3 months during 2 years]
Secondary	Overall cumulative duration of hospitalisation	calculated in days from randomization	throughout the duration of the study, during 2 years
Secondary	Number of interventional palliative procedures per patient	mean per patient from randomization	throughout the duration of the study, during 2 years