Status:

COMPLETED

Clinical Trial of Chemosensitivity Test

Lead Sponsor:

Japan Clinical Cancer Research Organization

Collaborating Sponsors:

Kitasato University

Conditions:

Gastric Cancer

Eligibility:

All Genders

20-80 years

Phase:

PHASE2

Brief Summary

To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery

Detailed Description

Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients. Chemosensitivity te...

Eligibility Criteria

Inclusion

  • histologically proven gastric cancer
  • PS (ECOG) 0 or 2
  • D2 dissection, curability B or more
  • surgical Stage IIIA and IIIB
  • negative peritoneal cytology
  • no previous radiotherapy, chemotherapy and hormone therapy
  • possible peroral intake at 6 POW
  • no severe surgical complication
  • normal bone marrow, liver and renal function
  • complete chemosensitivity test
  • written informed consent

Exclusion

  • multiple cancer
  • contraindication for S-1
  • history of drug allergy (grade 3)
  • severe complication
  • watery diarrhea
  • pregnant
  • scirrhous gastric cancer
  • the other patients who was judged as inadequate for trial by doctor on duty

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2011

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT00287755

Start Date

March 1 2006

End Date

March 1 2011

Last Update

June 29 2011

Active Locations (36)

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Page 1 of 9 (36 locations)

1

Nagoya University Hospital

Nagoya, Aichi-ken, Japan, 466-8550

2

Department of frontier surgery,Draduate school of medicine,Chiba University

Chiba, Chiba, Japan, 260-8670

3

Kyusyu University Faculty of Medical Sciences

Fukuoka, Fukuoka, Japan, 812-8582

4

Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, Fukuoka, Japan, 815-8588