GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514163
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : June 28, 2011
Information provided by:
Japan Clinical Cancer Research Organization

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine + S-1 Drug: gemcitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer
Study Start Date : June 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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:
  • gemzar
  • TS-1
Active Comparator: 2
Drug: gemcitabine
gemcitabine DIV on day one , 8th and 15th
Other Name: gemzar

Primary Outcome Measures :
  1. response rate [ Time Frame: during observation ]

Secondary Outcome Measures :
  1. median survival time(MST) [ Time Frame: during observation ]
  2. time-to-progression(TTP) [ Time Frame: from onset of regression to progression ]
  3. toxicity [ Time Frame: during observation ]
  4. clinical benefit response [ Time Frame: during observation ]

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically proven unresectable pancreatic carcinoma
  2. There must be measurable lesions with multislice CT
  3. ECOG Performance status 0-2
  4. No other active cancer
  5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy
  6. 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
  7. No serious complications
  8. Be able to eat food
  9. Life expectancy of more than 8 weeks duration
  10. Informed consent is obtained-

Exclusion Criteria:

  1. Interstitial pneumonia
  2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
  3. Serious infection
  4. Pregnant or lactating females
  5. History of serious drug allergy
  6. Serious other complications
  7. Uncontrolled mental disorders -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514163

Cancer Institute Ariake Hospital
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
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

Responsible Party: Takaaki Ikari, Cancer Institute Ariake Hospital Identifier: NCT00514163     History of Changes
Other Study ID Numbers: JACCRO PC-01
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by Japan Clinical Cancer Research Organization:
pancreatic carcinoma

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs