Clinical Trial: Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: University of California, San Francisco
Current Primary Outcome:
- To evaluate acute toxicities [ Time Frame: 3 months for acute toxicities ]
- To determine the maximal tolerated dose of the Cyberknife radiosurgery boost [ Time Frame: 3 months for acute toxicities ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess local and regional control [ Time Frame: two years ]
- To evaluate radiographic response [ Time Frame: two years ]
- To assess delayed and long-term toxicities [ Time Frame: two years ]
- To estimate disease specific and overall survival [ Time Frame: two years ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: February 28, 2008
Date Started: October 2007
Date Completion:
Last Updated: September 9, 2015
Last Verified: September 2015
