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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000173
Receipt No. R000000245
Scientific Title A phase II study of gemcitabine and S-1 combination therapy for metastatic pancreatic cancer
Date of disclosure of the study information 2005/10/01
Last modified on 2011/11/21

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Basic information
Public title A phase II study of gemcitabine and S-1 combination therapy for metastatic pancreatic cancer
Acronym Gemcitabine plus S-1 for pancreatic cancer
Scientific Title A phase II study of gemcitabine and S-1 combination therapy for metastatic pancreatic cancer
Scientific Title:Acronym Gemcitabine plus S-1 for pancreatic cancer
Region
Japan

Condition
Condition Metastatic pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of gemcitabine plus S-1 therapy for metastatic pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Adverse event
Progression free survival
Survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine+S-1
Interventions/Control_2
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven pancreatic adenocarcinoma or adeno-squamous cell carcinoma, 2)At least one measurable metastatic lesion, 3)Naïve to chemotherapy or radiotherapy (except for IORT), 4)Eastern Cooperative Oncology Group performance status of 0-1, 5)Age between 20 and 74 years, 6)Adequate organ function defined as white blood cell count of >=4,000/mm3 and <=12,000/mm3, neutrophil count of >=2,000/mm3, platelet count of >=100,000/mm3, hemoglobin >=9.0 g/dL, total bilirubin <=2.0 mg/dL (<=3.0 mg/dL if biliary drainage were present), and AST and ALT levels <=150 U/L, serum creatinine <=1.5 mg/dL, 7)Written informed consent
Key exclusion criteria 1)Pulmonary fibrosis or interstitial pneumonia, 2)Watery diarrhea, 3)Active infection (except for chronic viral hepatitis), 4)Severe complications, such as heart disease, renal failure, hepatic failure, and active gastric ulcer, 5)Marked pleural effusion or ascites, 6)Metastasis to the central nervous system, 7)Active concomitant malignancy, 8)Severe mental disorder, 9) Pregnancy or lactation
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Okusaka, MD, PhD
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ueno, MD, PhD
Organization GS Therapy Coordination Office
Division name National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email hiueno@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2005 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21715364
Number of participants that the trial has enrolled
Results
A total of 55 patients from 10 institutions were enrolled between October 2004 and July 2005. The efficacy and toxicity were analyzed in 54 patients who received at least one course of GS therapy. The median number of treatment courses was 7 (range, 1-24+). Although no complete response was seen, a partial response was achieved in 24 patients, resulting in an overall response rate of 44% (95% CI, 30.9-58.6%). Twenty-six patients (48%) had stable disease. The median progression-free survival was 5.9 months (95% CI, 4.1-6.9 months) and the median overall survival was 10.1 months (95% CI, 8.5-10.8 months) with a 1-year survival rate of 33%. The major grade 3-4 toxicities were neutropenia (80%), leucopenia (59%), thrombocytopenia (22%), anorexia (17%), rash (7%), nausea (6%) and fatigue (6%). Hematological toxicity was mostly transient and there was only one episode of infection with grade 3-4 neutropenia. No treatment-related deaths occurred during the study. In Conclusion, GS therapy produced a high response rate and good survival associated with an acceptable toxicity profile in patients with metastatic pancreatic cancer. A randomized phase III trial to confirm the efficacy of GS therapy is planned.
ASCO 2007 Gastrointestinal Cancers Symposium, Orlando, General poster session, 1/20/2007 (Abst. No 148)
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 Completed
Date of protocol fixation
2004 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
2006 Year 07 Month 01 Day
Date trial data considered complete
2006 Year 07 Month 01 Day
Date analysis concluded
2006 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2011 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000245

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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