To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.

• Conditions: Gastric Cancer
• Interventions: Procedure: Gastrectomy; Drug: oxaliplatin; Drug: S1; Drug: Docetaxel

• Registration Number: NCT03001726
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Detailed Description

Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-23
• Study Start: 2017-01
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-06
• Primary Completion: 2022-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Clinical diagnosis of gastric cancer with a single non-curable factor
• A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.

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Exclusion Criteria

• Patients who can have radical resection.
• Patietns who have more than one metastasis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastrectomy plus chemotherapy	S1	In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
chemotherapy alone	S1	Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.
Gastrectomy plus chemotherapy	Gastrectomy	In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
Gastrectomy plus chemotherapy	oxaliplatin	In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
Gastrectomy plus chemotherapy	Docetaxel	In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
chemotherapy alone	oxaliplatin	Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.
chemotherapy alone	Docetaxel	Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.

Primary Outcome Measures

Name	Time	Method
overall survival	through study completion, an average of 2 year

Secondary Outcome Measures

Name	Time	Method
progression-free survival	through study completion, an average of 1 year

Trial Locations

Locations (1)

Zhongshan hospital; 🇨🇳 Shanghai, Shanghai, China