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Completed

NCT Number: NCT01929421

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

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

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Key information

Conditions

Advanced Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gachon University Gil Medical Center

Incheon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine/S-1

Drug

Primary outcomes

  1. Response rate

    Time frame: 1year

Secondary outcomes

  1. overall survival

    Time frame: 1year

  2. number of participants with adverse events

    Time frame: 1year

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Aug 28, 2013
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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