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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00983541
First received: September 22, 2009
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Cancer
Drug: Fluorouracil (5-FU)
Radiation: Brachytherapy or SBRT (Stereotactic body radiation therapy)
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Definitive Chemoradiation With Gemcitabine and Continuous 5- FU (Fluorouracil)Followed by High Dose Rate Brachytherapy or Stereotactic Body Radiation Therapy Boost in Locally Advanced Intra or Extrahepatic Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • establish assessment of toxicity rates in patients with advanced hepatic cholangiocarcinoma when treated with gemcitabine every two weeks & 5-FU given concurrently with external beam radiation therapy , followed by brachytherapy or SBRT boost. [ Time Frame: September 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluate overall survival rate, progression free survival rate, tumor response rate, local control rate and rate of distant mets following gemcitabine and 5-FU with radiation therapy in patients with HCC [ Time Frame: September 2011 ] [ Designated as safety issue: No ]
  • evaluate the rate at which patients with unresectable extrahepatic cholangiocarcinoma become resectable following gemcitabine and radiation therapy. [ Time Frame: September 2011 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
Drug: Fluorouracil (5-FU)
5-FU Injection,USP (GeneraMedix Inc.) is effective in palliative management of carcinoma (colon, rectum, breast, stomach, pancreas) FDA approved in 1962-NDA (New Drug Application)012209. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy
Other Name: (5-FU)
Radiation: Brachytherapy or SBRT (Stereotactic body radiation therapy)
Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).
Other Name: brachytherapy or stereotactic body radiation therapy boost
Drug: Gemcitabine

Pancreatic:Indicated as first line treatment for patients with locally advanced (nonresectable Stage II or III) or metastatic(Stage IV) pancreatic adenocarcinoma.

Ovarian:Gemzar with carboplatin is indicated for treatment of patients with advanced ovarian cancer relapsed 6 months after plat-based therapy.

Breast:Gemzar with paclitaxel is indicated for first line treatment of patients with metastatic breast cancer after failed anthracycline-containing adjuvant chemotherapy, unless anthracyclines.

Non-small cell lung cancer(NSCLC):Gemzar is indicated with cisplatin for first line treatment of patients with inoperable, local advanced (Stage IIIA/IIIB), metastatic (Stage IV) NSCLC.

Other Name: Gemzar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 encompassible 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983541

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Christopher Anker, MD Huntsman Cancer Institute
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00983541     History of Changes
Other Study ID Numbers: HCI35306
Study First Received: September 22, 2009
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
intra or extrahepatic cholangiocarcinoma
liver cancer
liver
HCC
EHCC

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorouracil
Gemcitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014