Clinical Trial of Chemosensitivity Test | NCT00287755

ID	Type	Description	Link
GC-04

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Dec 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 3, 2006

First Submission Date that Met QC Criteria

Feb 3, 2006

First Posted Date

Feb 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2011

Last Update Posted Date

Jun 29, 2011Estimated

Name	Class
Kitasato University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: S-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-1	Drug	S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival rate		at three years

Secondary Outcomes

Measure	Description	Time Frame
Side effect		During administration of drug

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tetsuro Kubota, Processor	Keio University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya University Hospital		Nagoya	Aichi-ken	466-8550	Japan
Department of frontier surgery,Draduate school of medicine,Chiba University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26385385	Derived	Tanigawa N, Yamaue H, Ohyama S, Sakuramoto S, Inada T, Kodera Y, Kitagawa Y, Omura K, Terashima M, Sakata Y, Nashimoto A, Yamaguchi T, Chin K, Nomura E, Lee SW, Takeuchi M, Fujii M, Nakajima T. Exploratory phase II trial in a multicenter setting to evaluate the clinical value of a chemosensitivity test in patients with gastric cancer (JACCRO-GC 04, Kubota memorial trial). Gastric Cancer. 2016 Apr;19(2):350-360. doi: 10.1007/s10120-015-0506-z. Epub 2015 Sep 18.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases