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 |
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
PhaseI/II study of TS-1+CDDP in combination with Radiotherapy with unresectable and locally advanced for biliary tract cancer
Japan |
Biliary tract cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
[Phase I]
Estimate the maximum tolerated dose (MTD) and recommended dose (RD)
[Phase II]
Progression free survival (PFS)
[Phase I]
Response Rate, Adverse events
[Phase II]
Overall survival, Response Rate (RR), Resectable rate, Limited operation rate, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
[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).
20 | years-old | <= |
80 | years-old | > |
Male and Female
(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
(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
25
1st name | |
Middle name | |
Last name | Toshifumi Hibi |
Keio University
Gastroenterology and Hepatology
35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582
03-3353-1211
1st name | |
Middle name | |
Last name | Hajime Higuchi |
Keio University
Gastroenterology and Hepatology
35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582
03-3353-1211
higuchi@a2.keio.jp
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University
None
Self funding
NO
慶應義塾大学病院
2012 | Year | 03 | Month | 08 | Day |
Unpublished
Open public recruiting
2011 | Year | 07 | Month | 26 | Day |
2012 | Year | 03 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2012 | Year | 03 | Month | 08 | Day |
2012 | Year | 03 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008816