UMIN-CTR Clinical Trial

Basic information
Public title	PhaseI/II study of neoadjuvant TS-1+CDDP with concurrent radiation for biliary tract cancer
Acronym	PhaseI/II study of neoadjuvant TS-1+CDDP with concurrent radiation for biliary tract cancer
Scientific Title	PhaseI/II study of neoadjuvant TS-1+CDDP with concurrent radiation for biliary tract cancer
Scientific Title:Acronym	PhaseI/II study of neoadjuvant TS-1+CDDP with concurrent radiation for biliary tract cancer
Region	Japan

Condition
Condition	Biliary tract cancer
Classification by specialty	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 neoadjuvant chemoradiotherapy of S-1 with CDDP for biliary tract cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	(PhaseI) Estimate the maximum tolerated dose(MTD) and recommended dose(RD) (PhaseII) R0 resection rate
Key secondary outcomes	(PhaseI) Response Rate, Adverse events (PhaseII) Overall survival, 2 year survival rate, Progression Free Survival(PFS), Response Rate(RR), 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	Historical
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 of1.8 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 Stage II &#8211; IVa biliary tract cancer which could be resected(R0 or R1) (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 C9) oral intake 10)no abnormal finding by cardiac electrogram within 28 days 11)written informed consent cr: >=60 ml/min/body
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)pregnant women or during the nursing, women who like be pregnant and willing to get pregnant,men who want his partner to be pregnant (10)doctors decision not to be registered to this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Osamu Itano
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	Shinanomachi 35, shinjuku-ku
TEL	03-3353-1211
Email	contact@keio-hbpts.jp

Public contact
Name of contact person	1st name Middle name Last name Osamu Itano
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	Shinanomachi 35, shinjuku-ku
TEL	03-3353-1211
Homepage URL
Email	contact@keio-hbpts.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	non
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

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 05 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	Terminated
Date of protocol fixation	2012 Year 04 Month 01 Day
Date of IRB	2011 Year 08 Month 17 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 22 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 10 Month 03 Day
Last modified on	2019 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008794