Chemoradiation +Gemcitabine +Continuous 5-FU (Fluorouracil) Followed by High Dose Brachytherapy/Stereotactic Radiation Boost in Locally Advanced Intra/Extrahepatic Cholangiocarcinoma
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.
- 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.
- 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.
Drug: Fluorouracil (5-FU)
Radiation: Brachytherapy or SBRT (Stereotactic body radiation therapy)
|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|
- Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost. [ Time Frame: Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled. ] [ Designated as safety issue: Yes ]
- Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC [ Time Frame: 9 months. ] [ Designated as safety issue: No ]
- Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Evaluate Rate of Distant Mets Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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 boostDrug: 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00983541
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Christopher Anker, MD||Huntsman Cancer Institute|