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Recruitment status
Unique ID issued by UMIN UMIN000001103
Receipt No. R000001295
Scientific Title Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer
Date of disclosure of the study information 2008/04/01
Last modified on 2008/03/28

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Basic information
Public title Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer
Acronym KCGCOR-1
Scientific Title Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer
Scientific Title:Acronym KCGCOR-1
Region
Japan

Condition
Condition Patients with unresectable advanced pancreatic cancer (Stage IV, TNM Classification) who were primarily resistant to gemcitabine monotherapy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of TS-1 therapy and TS-1 plus gemcitabine combination therapy as a second-line chemotherapy for advanced pancreatic cancer (Stage IV, TNM Classification) who were resistant to gemcitabine as a first-line chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes disease control rate
Key secondary outcomes progression-free survival, overall survival, adverse event, QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm 1: S-1 monotherapy
Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1 arm, S-1 is given orally for four weeks, followed by a 2-week rest. as two divided doses (after breakfast and dinner), determined according to body surface area (BSA): BSA below 1.25 m2, 80 mg; 1.25 to 1.5 m2, 100 mg and BSA over1.5 m2, 120 mg. This course is repeated until progressive disease or severe toxicities are confirmed.
Interventions/Control_2 Arm 2: S-1/Gem
Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1/Gem arm, Gemcitabine (1000 mg/m2) is given by intravenous infusion over 30 minutes on days 8 and 15, followed by a 1-week rest. However, if the dose is reduced in patients during the first-line chemotherapy, administration should be started after reducing the dose of gemcitabine to 800 mg/m2.
S-1 is given orally for two weeks from Day 1 to 14, followed by a 1-week rest. as two divided doses (after breakfast and dinner), determined according to body surface area (BSA): BSA below 1.25 m2, 60 mg; 1.25 to 1.5 m2, 80 mg and BSA over1.5 m2, 100 mg.
This course is repeated until progressive disease or severe toxicities are confirmed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Eligible criteria in this study are as follows:
1)Cases with clinically proven carcinoma of the pancreas
2) Stage IV (TMN classification, UICC) unresectable patients.
3) Ages between 20 to 80 years old
4) An Eastern Cooperative Oncology Group performance status of 0 or 1. (Karnofsky performance status (KPS) of 70%)
5) Patients with solid tumor(s) which can be evaluated by Response Evaluation Criteria in Solid Tumours (RECIST) guidelines
6) Patients who previously had received gemcitabine monotherapy as the first-line chemotherapy and had been diagnosed as Progressive Disease (PD)
7) patients who experienced grade 4 hematologic toxicity are ineligible.
8) Patients must not have received any chemotherapy or radiotherapy for 3 weeks before entering this study
9) prior dose of the gemcitabine in the past chemotherapy>= 800 mg/m(2)
10) patients who are capable of oral intake.
11) Sufficient organ function within 1-week from the enrollment:
leukocytes >= 3,500 /mm3 and <= 12,000 /mm3, neutriphils >= 2,000 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 9.0 g/dL, serum total bilirubin <= 2 times from upper normal value of the facility, serum aspartate aminotransferase (AST) <= 2.5 times from upper normal value of the facility, serum alanine aminotransferase (ALT) <= 2.5 times from upper normal value of the facility, creatinin clearance>=60 mL/mil
12) Written informed consent
Key exclusion criteria Exclusion criteria are as follows:
1) Prior history of radiation therapy to pancreatic cancer
2) Presence of other active malignancy
3) Presence of severe complications such as plumonary fibrosis, interstitial pneumonia, intestinal paralysis, uncontrolled diabetes, uncontrolled hypertension, myocardial infarction within six months, unstable angina, severe infection, renal failure, liver failure, , etc
4) Past history of allergic reaction to gemcitabine
5) Regular use of frucitocin, fenitoin or warfarin
6) Past history of radiation therapy to the lung(s).
7) Massive ascites or pleural effusion
8) Severe diarrhea
9) active intestinal bleeding
10) Pregnancy, breast feeding, or women who desire to preserve fecundity or men who desire to have children
11) Severe mental disorder
12) regular use of steroids
13) Inadequate physical condition, as diagnosed by primary physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Hibi, MD
Organization Keio University School of Medicine, Department of Medicine
Division name Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Adachi, MD
Organization Keio University School of Medicine, Department of Medicine
Division name Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email adachi@sc.itc.keio.ac.jp

Sponsor
Institute Keio University School of Medicine, Department of Medicine, Division of Gastroenterology
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2007 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 28 Day
Last modified on
2008 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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