GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
gemcitabine + S-1
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic carcinoma, gemcitabine, S-1, phaseⅡstudy
Eligibility Criteria
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 -
Sites / Locations
- Cancer Institute Ariake Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
gemcitabine + S-1
S-1
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
median survival time(MST)
time-to-progression(TTP)
toxicity
clinical benefit response
Full Information
NCT ID
NCT00514163
First Posted
August 8, 2007
Last Updated
June 27, 2011
Sponsor
Japan Clinical Cancer Research Organization
1. Study Identification
Unique Protocol Identification Number
NCT00514163
Brief Title
GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
Official Title
Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Japan Clinical Cancer Research Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic carcinoma, gemcitabine, S-1, phaseⅡstudy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
gemcitabine + S-1
Arm Title
2
Arm Type
Active Comparator
Arm Description
S-1
Intervention Type
Drug
Intervention Name(s)
gemcitabine + S-1
Other Intervention Name(s)
gemzar, TS-1
Intervention Description
gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
gemzar
Intervention Description
gemcitabine DIV on day one , 8th and 15th
Primary Outcome Measure Information:
Title
response rate
Time Frame
during observation
Secondary Outcome Measure Information:
Title
median survival time(MST)
Time Frame
during observation
Title
time-to-progression(TTP)
Time Frame
from onset of regression to progression
Title
toxicity
Time Frame
during observation
Title
clinical benefit response
Time Frame
during observation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takaaki Ikari, MD. PhD
Organizational Affiliation
Cancer Institute Ariake Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Masafumi Suyama, M.D. PhD
Organizational Affiliation
Juntenndo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naoto Egawa, M.D. PhD
Organizational Affiliation
Komagome Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasuji Omuro, M.D. PhD
Organizational Affiliation
Komagome Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Takao Itoi, M.D. PhD
Organizational Affiliation
Tokyo Medical college
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atsushi Sofuni, M.D. PhD
Organizational Affiliation
Tokyo medical college
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute Ariake Hospital
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
12. IPD Sharing Statement
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GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
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