Biliary tract cancer
Conditions
Interventions
[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 da
Sponsors
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Phase I] Estimate the maximum tolerated dose (MTD) and recommended dose (RD) [Phase II] Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Phase I] Response Rate, Adverse events [Phase II] Overall survival, Response Rate (RR), Resectable rate, Limited operation rate, adverse events | — |
Countries
Japan
Contacts
Public ContactHajime Higuchi
Keio University Gastroenterology and Hepatology
Outcome results
None listed