Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of California, San Francisco |
---|---|
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00630890 |
The purpose of this study is to test the safety of giving external beam radiation, followed by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is not amenable for surgical removal, are eligible.
The hypothesis is that highly focused high dose radiation delivered using Cyberknife in conjunction with traditional radiation and chemotherapy can improve outcome in this patient population.
Condition | Intervention | Phase |
---|---|---|
Cholangiocarcinoma Klatskin Tumor Biliary Tract Cancer |
Radiation: External beam radiation and Cyberknife radiosurgery boost and capecitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor) |
Estimated Enrollment: | 11 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
External beam radiation with Cyberknife radiosurgery boost and concurrent capecitabine
|
Radiation: External beam radiation and Cyberknife radiosurgery boost and capecitabine
External Beam Radiation to 45 Gy Stereotactic Body Radiotherapy with Cyberknife to 20 Gy in 5 fractions dose escalation to 25 Gy in 5 fractions, and then 30 Gy in 5 fractions Capecitabine 825 mg/m2 q12 hours taken orally 5 days per week
|
This is a dose escalation study which will escalate the dose of Cyberknife radiosurgery boost after external beam radiation of 45 Gy with concurrent capecitabine. The three dose levels are 4 Gy x5, 5 Gy x5 and 6 Gy x 5, with 3 patients at each dose level. Dose-limiting toxicity (DLT) is defined as acute grade 3 liver or intestinal toxicity or any acute grade 4 toxicity. If one patient experienced a DLT at a particular dose level, the cohort should be expanded to 6 patients. The maximum tolerated dose (MTD) is defined as the dose level below that which results in DLT in 2 or more of the 6 patients in each cohort. At least 5 patients should be enrolled in the cohort of 6 Gy x 5 even if none of the first 3 experienced DLT, as a means of added verification of dose tolerance, at this upper limit of dose for this study.
The patient population includes any patients who have unresectable hilar cholangiocarcinoma without any prior history of radiation. We anticipate accruing 1 patient every 2 months; therefore, we estimate that it will require approximately 22 months to accrue 11 patients if no DLT is experienced by any patients requiring expansion of the cohorts.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have normal organ and marrow functions as defined below
Exclusion Criteria:
Contact: Kim Huang, M.D. | 415-353-8900 | khuang@radonc.ucsf.edu |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143-0226 | |
Contact: Kim Huang, M.D. 415-353-8900 khuang@radonc.ucsf.edu | |
Principal Investigator: Kim Huang, M.D. |
Principal Investigator: | Kim Huang, M.D. | University of California, San Francisco |
Responsible Party: | Department of Radiation Oncology, UCSF ( Kim Huang, M.D./Assistant Professor ) |
Study ID Numbers: | 07455 |
Study First Received: | February 28, 2008 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00630890 |
Health Authority: | United States: Institutional Review Board |
Hilar Cholangiocarcinoma (Klatskin Tumor) External Beam Radiation Cyberknife Capecitabine |
Cholangiocarcinoma Capecitabine Biliary Tract Neoplasms Digestive System Neoplasms Biliary tract cancer Klatskin tumor Carcinoma |
Digestive System Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Adenocarcinoma Klatskin's Tumor Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |