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Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

Primary Purpose

Cholangiocarcinoma, Klatskin Tumor, Biliary Tract Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
External beam radiation and Cyberknife radiosurgery boost and capecitabine
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Hilar Cholangiocarcinoma (Klatskin Tumor), External Beam Radiation, Cyberknife, Capecitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

External beam radiation with Cyberknife radiosurgery boost and concurrent capecitabine

Outcomes

Primary Outcome Measures

To evaluate acute toxicities
To determine the maximal tolerated dose of the Cyberknife radiosurgery boost

Secondary Outcome Measures

To assess local and regional control
To evaluate radiographic response
To assess delayed and long-term toxicities
To estimate disease specific and overall survival

Full Information

First Posted
February 28, 2008
Last Updated
September 9, 2015
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00630890
Brief Title
Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)
Official Title
Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
investigator left UCSF and study was closed prematurely in 2008. No results to report.
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Klatskin Tumor, Biliary Tract Cancer
Keywords
Hilar Cholangiocarcinoma (Klatskin Tumor), External Beam Radiation, Cyberknife, Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
External beam radiation with Cyberknife radiosurgery boost and concurrent capecitabine
Intervention Type
Radiation
Intervention Name(s)
External beam radiation and Cyberknife radiosurgery boost and capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate acute toxicities
Time Frame
3 months for acute toxicities
Title
To determine the maximal tolerated dose of the Cyberknife radiosurgery boost
Time Frame
3 months for acute toxicities
Secondary Outcome Measure Information:
Title
To assess local and regional control
Time Frame
two years
Title
To evaluate radiographic response
Time Frame
two years
Title
To assess delayed and long-term toxicities
Time Frame
two years
Title
To estimate disease specific and overall survival
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Huang, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0226
Country
United States

12. IPD Sharing Statement

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Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

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