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

Stopped early · Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00983541

Run by

University of Utah

People needed

1

Starts

2009-09-01

Expected to finish

2012-03-01

Last updated by the study team

2015-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients over age 18
• 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
• Deemed surgically unresectable by a surgical oncologist
• Malignant disease encompassable within a single radiation field
• ECOG 0-2
• Laboratory values: Hemoglobin ≥ 8.0 (can be transfused to attain this value), Granulocytes > 1,500, platelets > 100,000/ul

You may not qualify if…

• Chemotherapy within one month of starting radiation therapy
• Previous abdominal radiotherapy
• Uncontrolled infection or severe active comorbid disease
• Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
• Distant metastatic disease (outside regional lymph nodes)
• Pregnancy or lactating women

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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