A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer

Phase 2

Terminated

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: S-1 plus oxaliplatin

• Registration Number: NCT01946061
• Lead Sponsor: Yonsei University

Brief Summary

Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Study Start: 2015-05
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Age, between 19 and 75
• Histologically proven advanced gastric cancer
• R0 resection after D2 gastrectomy
• Stage III (according to the AJCC 7th criteria)
• ECOG status 0 to 2

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Exclusion Criteria

• Malignancy history other than gastric cancer
• Previous chemotherapy history for gastric cancer
• Previous radiotherapy history for gastric cancer
• Pregnancy or breast milk feeding
• Grade 3 or more of neuropathy
• Active infection
• Severe hepatic dysfunction
• Severe renal dysfunction
• Severe bone marrow dysfunction
• Significant neurologic or psychologic disease
• Inadequate condition for receiving chemotherapy due to significant systemic disease
• Patients who receives drugs which can be interacted with S-1

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	S-1 plus oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival	3 years from the surgery	3-year disease-free survival will be assessed by imaging study including CT and PET.

Trial Locations

Locations (1)

Severnace Hospital; 🇰🇷 Seoul, Korea, Republic of