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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007473
Receipt No. 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

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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
Email

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
Email higuchi@a2.keio.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008816

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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