GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
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Purpose
The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: gemcitabine + S-1 Drug: gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer |
- response rate [ Time Frame: during observation ] [ Designated as safety issue: No ]
- median survival time(MST) [ Time Frame: during observation ] [ Designated as safety issue: No ]
- time-to-progression(TTP) [ Time Frame: from onset of regression to progression ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: during observation ] [ Designated as safety issue: Yes ]
- clinical benefit response [ Time Frame: during observation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
gemcitabine + S-1
|
Drug: gemcitabine + S-1
gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
Other Names:
|
|
Active Comparator: 2
S-1
|
Drug: gemcitabine
gemcitabine DIV on day one , 8th and 15th
Other Name: gemzar
|
Detailed Description:
Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically proven unresectable pancreatic carcinoma
- There must be measurable lesions with multislice CT
- ECOG Performance status 0-2
- No other active cancer
- No previous therapy such as radiotherapy, chemotherapy and immunotherapy
- Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
- No serious complications
- Be able to eat food
- Life expectancy of more than 8 weeks duration
- Informed consent is obtained-
Exclusion Criteria:
- Interstitial pneumonia
- Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
- Serious infection
- Pregnant or lactating females
- History of serious drug allergy
- Serious other complications
- Uncontrolled mental disorders -
Contacts and Locations| Japan | |
| Cancer Institute Ariake Hospital | |
| Tokyo, Japan, 135-8550 | |
| Principal Investigator: | Takaaki Ikari, MD. PhD | Cancer Institute Ariake Hospital |
| Principal Investigator: | Masafumi Suyama, M.D. PhD | Juntenndo University Hospital |
| Principal Investigator: | Naoto Egawa, M.D. PhD | Komagome Hospital |
| Principal Investigator: | Yasuji Omuro, M.D. PhD | Komagome Hospital |
| Principal Investigator: | Takao Itoi, M.D. PhD | Tokyo Medical college |
| Principal Investigator: | Atsushi Sofuni, M.D. PhD | Tokyo medical college |
More Information
No publications provided
| Responsible Party: | Takaaki Ikari, Cancer Institute Ariake Hospital |
| ClinicalTrials.gov Identifier: | NCT00514163 History of Changes |
| Other Study ID Numbers: | JACCRO PC-01 |
| Study First Received: | August 8, 2007 |
| Last Updated: | June 27, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Cancer Research Organization:
|
pancreatic carcinoma gemcitabine S-1 phaseⅡstudy |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013