NCT00142350CompletedPhase 3
Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
Japan Clinical Oncology Group34 sites in 1 country690 target enrollmentStarted: November 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 690
- Locations
- 34
- Primary Endpoint
- overall survival
Study Overview
Brief Summary
To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
Detailed Description
From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •unresectable or recurrent histologically proved gastric cancer
- •adequate oral intake
- •age 20 or older and 75 or younger
- •Performance Status (ECOG):0, 1, 2
- •measurable or unmeasurable lesions
- •preserved organ functions
- •no severe medical condition
- •no prior chemotherapy for gastric cancer
- •written informed consent
Exclusion Criteria
- •patient with marked infection or inflammation
- •patient with severe peritoneal metastasis
- •patient with massive pleural effusion
- •patient with metastasis to CNS
- •patient with diarrhea 4 or more times per day
- •patient severe medical condition
- •patient with other concurrent malignancy affecting on survival or adverse events
- •pregnant or nursing patient or with intent to bear baby
- •patient evaluated to be inadequate by a attending doctor
- •patient requiring nutritional support
Outcomes
Primary Outcomes
overall survival
Secondary Outcomes
- time to treatment failure
- incidences of adverse events
- response rate
- non-hospitalized survival
Investigators
Study Sites (34)
Loading locations...
Similar Trials
Unknown
Phase 2
ILF With/Without Cisplatin for Advanced Gastric CancerStomach NeoplasmNCT00320294Gachon University Gil Medical Center86
Completed
Phase 3
A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)Sensitive relpased small-cell lung cancerJPRN-UMIN000000828Japan Clinical Oncology Group(JCOG)180
Recruiting
Not Applicable
A phase II study of Irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancerNeoplasmsKCT0000670Seoul National University Hospital23
Terminated
Phase 1
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal CancerDiarrheaColorectal NeoplasmsNCT00036517PhytoCeutica30
Terminated
Phase 1
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00819754Ottawa Hospital Research Institute23