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Clinical Trials/JPRN-C000000282
JPRN-C000000282
Completed
Phase 1

Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer Step 2: low dose cisplatin given twice a week + S-1

Japanese Foundation for Multidisciplinary Treatment of Cancer0 sites52 target enrollmentNovember 14, 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
unresectable or recurrent gastric cancer
Sponsor
Japanese Foundation for Multidisciplinary Treatment of Cancer
Enrollment
52
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 14, 2005
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Japanese Foundation for Multidisciplinary Treatment of Cancer

Eligibility Criteria

Inclusion Criteria

  • 1\) Histologically or cytologically demonstrated unresectable or recurrent gastric cancer
  • 2\) With measurable or assessable legion(s)
  • 3\) Without prior anti\-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible.
  • 4\) Adequate bone marrow, hepatic and renal function
  • (1\)Hb \>\= 9\.0 g/dl
  • (2\)WBC 4,000 \- 12,000/mm3
  • (3\)neutrophils \>\= 2,000/mm3
  • (4\)platelets \>\= 100,000/ mm3
  • (5\)T\-Bil \<\= 1\.5mg/dl
  • (6\)GOT, GPT \<\= 2\.5 times of normal upper limits

Exclusion Criteria

  • 1\) severe complication(s)
  • 2\) symptomatic brain metastases
  • 3\) active double cancers
  • 4\) women who are currently pregnant, nursing, or plan to become pregnant
  • 5\) cases where the investigator disapproved of participation

Outcomes

Primary Outcomes

Not specified

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