NCT01929421

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3.5 years

First QC Date

August 19, 2013

Last Update Submit

May 9, 2018

Conditions

Advanced Colorectal Cancer

Keywords

colorectal cancergemcitabineS-1

Outcome Measures

Primary Outcomes (1)

  • Response rate

    1year

Secondary Outcomes (2)

  • overall survival

    1year

  • number of participants with adverse events

    1year

Study Arms (1)

Gemcitabine/ s-1

EXPERIMENTAL
Drug: Gemcitabine/S-1

Interventions

Gemcitabine/S-1DRUG
Gemcitabine/ s-1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • other tumor type than adenoarcinoma.
  • presence or history of CNS metastasis.
  • evidence of gastrointestinal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 28, 2013

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

December 1, 2014

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

KR(1)