Back to resultsA Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
Primary Purpose
Advanced Gastric Cancer
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1 plus oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Oxaliplatin, S-1, Gastric cancer, Adjuvant chemotherapy
Eligibility Criteria
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
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
Sites / Locations
- Severnace Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
3-year disease-free survival
3-year disease-free survival will be assessed by imaging study including CT and PET.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01946061
Brief Title
A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped because of difficulties of supplying the drug.
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
Oxaliplatin, S-1, Gastric cancer, Adjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S-1 plus oxaliplatin
Intervention Description
Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.
Primary Outcome Measure Information:
Title
3-year disease-free survival
Description
3-year disease-free survival will be assessed by imaging study including CT and PET.
Time Frame
3 years from the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Facility Information:
Facility Name
Severnace Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
17978289
Citation
Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252. Erratum In: N Engl J Med. 2008 May 1;358(18):1977.
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A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
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