Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

September 9, 2015 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0226
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age eighteen years or older
  • Histological defined unresectable cholangiocarcinoma of hilar region of the liver
  • Patients should have evaluable disease on one or more imaging modalities (CT scan, MRI, and/or PET) since this will be necessary for radiation treatment planning. However, because the borders of these tumors are sometimes difficult to define precisely, measurable disease is not required (see Section 9.1 for definitions of evaluable and measurable disease).
  • The maximum tumor dimension should be less than 6 cm.
  • Patients with pathologically enlarged perihepatic regional lymph nodes are allowed.
  • Prior surgical resection is allowed if there is gross disease remaining
  • Adjuvant chemotherapy is allowed at least 1 month after completion of radiation therapy if any grade 3 or higher toxicity has resolved
  • Percutaneous biliary drains and biliary stents are allowed
  • Performance status of ECOG 0-1 (see Appendix I)
  • Life expectancy greater than 6 months

  • Subject must have normal organ and marrow functions as defined below

    • leukocytes >3,000/mcL
    • absolute neutrophil count >1,500/mcL
    • platelets >100,000/mcL
    • total bilirubin <2.5 X institutional upper limit of normal
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
    • PT/PTT within normal institutional limits
  • Gold marker seeds (1 to 3) are required to be placed in or around the primary tumor by an interventional radiologist
  • Ability to give written informed consent and willingness to comply with the requirements of the protocol
  • Women of child-bearing potential must agree to use an effective method of birth control during treatment and for six months after receiving their last dose of treatment

Exclusion Criteria:

  • Patients who have had prior chemotherapy
  • Patients who have had external beam radiation to the region of liver hilar previously.
  • Patients receiving any other investigational agents
  • Patients with known metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who are not candidates for gold marker seeds placement due to position of the tumor or co-existing medical condition.
  • Pregnant or lactating women and women of child-bearing potential who are not using an effective method of birth control
  • Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate acute toxicities
Time Frame: 3 months for acute toxicities
3 months for acute toxicities
To determine the maximal tolerated dose of the Cyberknife radiosurgery boost
Time Frame: 3 months for acute toxicities
3 months for acute toxicities

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess local and regional control
Time Frame: two years
two years
To evaluate radiographic response
Time Frame: two years
two years
To assess delayed and long-term toxicities
Time Frame: two years
two years
To estimate disease specific and overall survival
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Kim Huang, M.D., University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07455

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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