UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000173 |
|---|---|
| Receipt number | 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 15:17:20 |
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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
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
hiueno@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000245
