Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate acute toxicities
3 months for acute toxicities
Kim Huang, M.D.
University of California, San Francisco
United States: Institutional Review Board
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