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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01929421
Other study ID # 2009-GIRBA-2075
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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