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Clinical Trial of Chemosensitivity Test

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ClinicalTrials.gov Identifier: NCT00287755
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : June 29, 2011
Sponsor:
Collaborator:
Kitasato University
Information provided by:
Japan Clinical Cancer Research Organization

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Phase 2

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 test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on duty.

Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year after operation.

Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs.

Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable survival outcome comparing with resistant cases.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
Study Start Date : March 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: S-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.




Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: at three years ]

Secondary Outcome Measures :
  1. Side effect [ Time Frame: During administration of drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287755


Locations
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Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Kitasato University
Investigators
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Principal Investigator: Tetsuro Kubota, Processor Keio University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tetsurou Kubota / Professor, Center of Comprehensive and Advanced Medicine, Keio University
ClinicalTrials.gov Identifier: NCT00287755    
Other Study ID Numbers: JACCRO GC-04
GC-04
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011
Keywords provided by Japan Clinical Cancer Research Organization:
gastric cancer
S-1
chemosensitivity
adjuvant
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases