Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Biliary Tract Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

External beam radiation with Cyberknife radiosurgery boost and concurrent 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

External beam radiation and Cyberknife radiosurgery boost and capecitabine

Kim Huang, M.D.

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.

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.

Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor)

University of California, San Francisco

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)	NCT00630890	Cholangiocarcin... Klatskin Tumor Biliary Tract C...	External beam r...	18 Years -	University of California, San Francisco
Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)	NCT00630890	Cholangiocarcin... Klatskin Tumor Biliary Tract C...	External beam r...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for external beam radiation and cyberknife radiosurgery boost and capecitabine