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

Gachon University Gil Medical Center

Status and phase: Completed; Phase 2

Conditions: Advanced Colorectal Cancer

Treatments: Drug: Gemcitabine/S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01929421

2009-GIRBA-2075

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Gemcitabine/ s-1

Experimental group

Treatment:

Drug: Gemcitabine/S-1