Know Cancer

or
forgot password

Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)


Phase 3
20 Years
75 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)


From the results of our previous phase III study (JCOG9205), continuous infusion of
5-fluorouracil has remained to be a control arm of this study. This study investigates the
superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral
fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall
survival, and the planned number of enrolled patients is 690 (230/arm).


Inclusion Criteria:



1. unresectable or recurrent histologically proved gastric cancer

2. adequate oral intake

3. age 20 or older and 75 or younger

4. Performance Status (ECOG):0, 1, 2

5. measurable or unmeasurable lesions

6. preserved organ functions

7. no severe medical condition

8. no prior chemotherapy for gastric cancer

9. written informed consent

Exclusion Criteria:

1. patient with marked infection or inflammation

2. patient with severe peritoneal metastasis

3. patient with massive pleural effusion

4. patient with metastasis to CNS

5. patient with diarrhea 4 or more times per day

6. patient severe medical condition

7. patient with other concurrent malignancy affecting on survival or adverse events

8. pregnant or nursing patient or with intent to bear baby

9. patient evaluated to be inadequate by a attending doctor

10. patient requiring nutritional support

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Principal Investigator

Atsushi Ohtsu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Centr Hospital East

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG9912

NCT ID:

NCT00142350

Start Date:

November 2000

Completion Date:

January 2007

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • 5-fluorouracil
  • irinotecan
  • cisplatin
  • S-1
  • advanced or recurrent gastric cancer
  • Stomach Neoplasms

Name

Location