A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.

Phase 2

Completed

• Conditions: Advanced Colorectal Cancer
• Interventions: Drug: Gemcitabine/S-1

• Registration Number: NCT01929421
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2013-06
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-28
• Study Completion: 2014-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• non resectable colorectal adenocarcinoma.
• disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens.
• estimated life expectancy of more than 3 months.
• ECOG status 2 or lower

Exclusion Criteria

• other tumor type than adenoarcinoma.
• presence or history of CNS metastasis.
• evidence of gastrointestinal bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine/ s-1	Gemcitabine/S-1	-

Primary Outcome Measures

Name	Time	Method
Response rate	1year

Secondary Outcome Measures

Name	Time	Method
overall survival	1year
number of participants with adverse events	1year

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of