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

Advanced Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929421
• Other study ID #: 2009-GIRBA-2075
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2018
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Gemcitabine/S-1

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		1year
Secondary	overall survival		1year
Secondary	number of participants with adverse events		1year