Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

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Taiho Pharma

Status and phase

Completed
Phase 3

Conditions

Gastric Cancer

Treatments

Drug: TS-1 and cisplatin
Drug: TS-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150670
91023039

Details and patient eligibility

About

This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.

Full description

This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed adenocarcinoma
  • Unresectable and recurrent gastric cancer
  • Age 20 to 74
  • Performance status 0, 1, or 2 (ECOG)
  • Life expectancy 3 months
  • No prior chemotherapy or radiotherapy for gastric cancer
  • Able to take oral medication
  • Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
  • Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL
  • Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
  • Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

Exclusion criteria

  • Pregnant or nursing
  • Bleeding from gastrointestinal tract or no diarrhea
  • Hypersensitivity to TS-1 or CDDP
  • Psychiatric disorder that would preclude study compliance or giving informed consent
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality
  • Serious illness or medical condition
  • Brain metastasis
  • Ascites requiring drainage

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

1
Experimental group
Description:
TS-1 and cisplatin
Treatment:
Drug: TS-1 and cisplatin
2
Active Comparator group
Description:
TS-1
Treatment:
Drug: TS-1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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