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.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00983541
First received: September 22, 2009
Last updated: July 23, 2015
Last verified: July 2015
Results First Received: June 21, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: Fluorouracil (5-FU)
Radiation: Brachytherapy or SBRT (Stereotactic body radiation therapy)
Drug: Gemcitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Patients

All participants enrolled.

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).

Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy

Gemcitabine


Participant Flow:   Overall Study
    All Patients  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Patients

All participants enrolled.

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).

Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy

Gemcitabine


Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC   [ Time Frame: 9 months ]

3.  Secondary:   Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy.   [ Time Frame: 9 months ]

4.  Secondary:   Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC   [ Time Frame: 9 months ]

5.  Secondary:   Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC   [ Time Frame: 9 months. ]

6.  Secondary:   Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC   [ Time Frame: 9 months ]

7.  Secondary:   Evaluate Rate of Distant Mets Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC   [ Time Frame: 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christopher Anker, MD
Organization: Huntsman Cancer Institute
phone: 801-213-4241
e-mail: candace.larson@hci.utah.edu


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
Results First Received: June 21, 2013
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board