UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000486 |
|---|---|
| Receipt number | R000000590 |
| Scientific Title | A Phase II trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2006/09/12 |
| Last modified on | 2010/09/13 00:39:40 |
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Basic information
Public title
A Phase II trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer
Acronym
S-1 and concurrent radiotherapy for locally advanced pancreatic cancer
Scientific Title
A Phase II trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer
Scientific Title:Acronym
S-1 and concurrent radiotherapy for locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and toxicity of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Survival and adverse events
Key secondary outcomes
Progression free survival, response rate, and CA19-9 response.
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
Concurrent radiotherapy with S-1 and maintenance therapy of S-1 was administered until disease progression or unacceptable toxicity.
Concurrent radiotherapy with S-1:
S-1; 80mg/m2 on the irradiated day.
Radiotherapy; a total dose of 50.4 Gy in 28 fractions over 5.5 weeks.
Maintenance therapy of S-1:
80mg/m2 for 28 days, followed by a rest period of 14 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients eligible for study entry had locally advanced pancreatic cancer.
Eligibility criteria were:
1)Histologically or cytologically proven adenocarcinoma
2)No prior treatment for pancreatic cancer
3)All pancreas lesions and lymph node metastases are included in the radiation field, 10 x 10 cm
4)Aged 20 years or over
5)An Eastern Cooperative Oncology Group performance status of 0-2
6)Adequate oral intakes
7)Sufficient organ function: leukocytes >= 3,500 /mm3, hemoglobin >= 9 g/dL, platelets >= 100,000 /mm3, serum albumin >= 3.0 g/dL, serum total bilirubin <= 2.0 mg/dL (or 3.0mg/dL if biliary drainage were present), serum transaminases (aspartate aminotransferase (AST) / alanine aminotransferase (ALT)) <= 100 U/L (or 150U/L if biliary drainage were present), and serum creatinine <= upper normal limit
8)Written informed consent.
Key exclusion criteria
1)Watery diarrhea
2)Use of phenytoin, warfarin potassium, or flucytosine
3)Pleural effusion or ascites
4)Active infection
5)Active concomitant malignancy
6)Active gastroduodenal ulcer
7)Severe complication, such as heart disease, renal disease, and hepatic disease
8)Severe mental disorder
9) Severe allergic reaction to drug
10)Active concomitant malignancy, pregnant and lactating females, and females of childbearing age unless using effective contraception
Target sample size
60
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 | Masafumi Ikeda, MD. |
Organization
S-1 Radiation Coordinating Office
Division name
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
masikeda@ncc.co.jp
Sponsor or person
Institute
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
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
| 2006 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2006 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 09 | Month | 12 | Day |
Last modified on
| 2010 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000590
