Chemoradiation +Gemcitabine +Continuous 5-FU (Fluorouracil) Followed by High Dose Brachytherapy/Stereotactic Radiation Boost in Locally Advanced Intra/Extrahepatic Cholangiocarcinoma

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible.

Primary Objectives

• To establish a preliminary assessment whether toxicity rates are acceptable in patients with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a regimen of gemcitabine every two weeks and continuous fluorouracil (5-FU) given concurrently with external beam radiation therapy to a total dose of 45 gray(Gy), followed by a brachytherapy or Stereotactic Body Radiation Therapy(SBRT) boost.

Secondary Objectives

• To evaluate the overall survival rate, progression free survival rate, tumor response rate, local control rate and the rate of distant metastases following gemcitabine and continuous 5-FU concurrent with radiation therapy in patients with locally advanced intra or extrahepatic cholangiocarcinoma.

• To evaluate the rate at which patients with unresectable extrahepatic cholangiocarcinoma become resectable following gemcitabine and radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Fluorouracil; Gemcitabine

Criteria

Inclusion Criteria:

1. Patients over age 18

2. Intra or extrahepatic cholangiocarcinoma confirmed by biopsy/brushings, biliary aneuploidy demonstrated by FISH, or elevated CA 19-9 greater than 100 ng/mL in the presence of a radiographic malignant stricture

3. Deemed surgically unresectable by a surgical oncologist

4. Malignant disease encompassable within a single radiation field

5. ECOG 0-2

6. Laboratory values: Hemoglobin ≥ 8.0 (can be transfused to attain this value), Granulocytes > 1,500, platelets > 100,000/ul

Exclusion Criteria:

1. Chemotherapy within one month of starting radiation therapy

2. Previous abdominal radiotherapy

3. Uncontrolled infection or severe active comorbid disease

4. Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer

5. Distant metastatic disease (outside regional lymph nodes)

6. Pregnancy or lactating women