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

NCT ID: NCT01929421

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2014-12-31

Brief Summary

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

Conditions

Advanced Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine/ s-1

Group Type: EXPERIMENTAL

Gemcitabine/S-1

Intervention Type: DRUG

Interventions

Gemcitabine/S-1

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hee Kyung Ahn

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gachon University Gil Medical Center

Incheon, , South Korea

Countries

South Korea

Other Identifiers

2009-GIRBA-2075

Identifier Type: -

Identifier Source: org_study_id