KCT0003478
Withdrawn
N/A
A Phase II Study of concurrent chemo-radiotherapy with Gemcitabine followed by chemotherapy with Gemcitabine and Cisplatin for unresectable localized perihilar cholangiocarcinoma
CC Hospital0 sites27 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- CC Hospital
- Enrollment
- 27
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed adenocarcinoma located in the bile duct of the liver,
- •If surgically unresectable
- •If there is no systemic and intrahepatic metastasis
- •If there is biliary obstruction, there is no obstruction due to drainage before the clinical trial
- •If the tumor is included in the radiation field (maximum: 10 x 10 cm)
- •If the tumor is measurable,
- •If there is no history of radiation therapy in the abdomen
- •Age: \= 18 years old
- •Performance status: ECOG 0\-1
- •With adequate bone marrow, renal, and liver function: HB \=9\.0 g/dl, ANC \=1,500/mm3, PLT \= 100,000/mm3, Bilirubin \<3\.0 mg/dl, AST/ALT/ALP): \< WNL X 3, Creatinine: \<WNL x 1\.5
Exclusion Criteria
- •Biliary cancer of other histological type except adenocarcinoma.
- •Cholangiocarcinoma with a epicenter other than perhilar area
- •In case of peritoneal seeding and distant metastasis
- •Performance status: ECOG 2\-4\.Previous radiotherapy history to target area
- •The patients with other tumors not treated in addition to biliary cancer within the last 2 years. However, cervical intraepithelial and thyroid cancer and early (I, II) prostate cancer are acceptable.
- •If you have any of the following serious systemic diseases: congestive heart failure (NYHA class III or IV); unstable angina within the last 6 months, myocardial infarction, Arrhythmia requiring treatment beyond 2nd degree AV block, uncontrolled hypertension, Child C liver cirrhosis, interstitial pneumonia, pulmonary adenomatosis, Mental illness that may interfere with treatment and clinical trials, unstable diabetes mellitus, uncontrolled ascites or pleural effusion, active infection
- •If the investigator judges that the patient is inadequate to participate in the clinical trial
Outcomes
Primary Outcomes
Not specified
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