UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007473 |
|---|---|
| Receipt number | R000008816 |
| Scientific Title | PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer |
| Date of disclosure of the study information | 2012/03/08 |
| Last modified on | 2012/03/08 18:43:05 |
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Basic information
Public title
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
Acronym
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
Scientific Title
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
Scientific Title:Acronym
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Estimate the maximum tolerated dose (MTD) and recommended dose (RD), and evaluate the efficacy and tolerability of S-1 with CDDP in combination with Radiotherapy for unresectable and locally advanced for biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
[Phase I]
Estimate the maximum tolerated dose (MTD) and recommended dose (RD)
[Phase II]
Progression free survival (PFS)
Key secondary outcomes
[Phase I]
Response Rate, Adverse events
[Phase II]
Overall survival, Response Rate (RR), Resectable rate, Limited operation rate, adverse events
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
[TS-1]
TS-1 is orally administered twice daily from day 1 to 14 and day 29 to 42 according to body surface area.
[CDDP]
CDDP is administered intravenously over 2 hours in each dosage of level at day 1 and 29.
[Radiation]
Radiation is delivered a total dose of 50.4 Gy (28 fractions of 1.8 Gy).
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which histologically confirmed adenocarcinoma or Adenosquamous carcinoma
(2) patients with unresectable and locally advanced for biliary tract cancer
(3) with no prior chemotherapy or radiation to biliary tract cancer
(4) Radiotherapist judges that we can include primary tumor and all lymph node metastases in the radiation field of 10cm *10cm by abdominal CT or MRI.
(5) evaluable lesion is confirmed with objective documents such as CT within 28th before registration, MRI, the X-ray examination.
(6) age >=20
(7) ECOG P.S. 0-1
(8) oral intake
(9) sufficient function of important organs
WBC >=3,500/mm3
Neut >=2000/mm3
Platelet >=100,000/mm3
Hem >=9.0g/dl
Alb >=3.0g/dL
AST, ALT: <= 100IU/l ((or 150U/L if biliary drainage were present)
sT.bil: <=2.0mg/dl (or <=2.0mg/dl if biliary drainage were present)
serum Cr: <= Upper limit of normal
Ccr: >=60 ml/min/body
(10) oral intake
(11) no abnormal finding by cardiac electrogram within 28 days
(12) written informed consent
Key exclusion criteria
(1) bowel movement control is difficult, because of watery diarrhea and chronic diarrhea.
(2) administered flucytosine, Phenytoin, Warfarin potassium
(3) Pleural effusion or ascitic fluid accumulates
(4) with clinically important infection
(5) has active carcinoma except carcinoma in situ
(6) with gastrointestinal active ulcer
(7) sever complication (Heart failure, renal failure, liver failure, Intestinal paralysis, uncontrollable diabetes etc)
(8) severe mental disorder
(9) severe drug allergy
(10) pregnant women or during the nursing, women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant
(11) doctor's decision not to be registered to this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
Keio University
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Higuchi |
Organization
Keio University
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582
TEL
03-3353-1211
Homepage URL
higuchi@a2.keio.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | 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
| 2012 | Year | 03 | Month | 08 | Day |
Last modified on
| 2012 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008816
