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Sponsored by: |
Taiho Pharmaceutical Co., Ltd. |
Information provided by: | Taiho Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00498225 |
In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time.
Condition | Intervention | Phase |
Pancreatic Cancer |
Drug: Gemcitabine plus TS-1 Drug: TS-1 Drug: Gemcitabine |
Phase III |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine S 1 (Combination) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis) |
Estimated Enrollment: | 750 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Gemcitabine plus TS-1
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Drug: Gemcitabine plus TS-1
Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
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2: Experimental
TS-1
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Drug: TS-1
TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
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3: Active Comparator
Gemcitabine
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Drug: Gemcitabine
Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Takuji Okusaka, MD | +81-3-3542-2511 | tokusaka@ncc.go.jp |
Japan | |||||
National Cancer Center Hospital | Recruiting | ||||
Tokyo, Japan, 104-0045 | |||||
Contact: Takuji Okusaka, MD +81-3-3542-2511 tokusaka@ncc.go.jp | |||||
Contact: Hideki Ueno, MD +81-3-3542-2511 hiueno@ncc.go.jp | |||||
Principal Investigator: Takuji Okusaka, MD |
Taiho Pharmaceutical Co., Ltd. |
Principal Investigator: | Takuji Okusaka, MD | National Cancer Center Hospital |
Responsible Party: | Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. ) |
Study ID Numbers: | 01023017 |
First Received: | July 6, 2007 |
Last Updated: | July 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00498225 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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