Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

This study has been terminated.
(investigator left UCSF and study was closed prematurely in 2008. No results to report.)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00630890
First received: February 28, 2008
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Klatskin Tumor
Biliary Tract Cancer
Radiation: External beam radiation and Cyberknife radiosurgery boost and capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • To evaluate acute toxicities [ Time Frame: 3 months for acute toxicities ] [ Designated as safety issue: Yes ]
  • To determine the maximal tolerated dose of the Cyberknife radiosurgery boost [ Time Frame: 3 months for acute toxicities ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess local and regional control [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • To evaluate radiographic response [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • To assess delayed and long-term toxicities [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • To estimate disease specific and overall survival [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 11
Study Start Date: October 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Xeloda

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630890

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143-0226
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kim Huang, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: Kim Huang, M.D./Assistant Professor, Department of Radiation Oncology, UCSF
ClinicalTrials.gov Identifier: NCT00630890     History of Changes
Other Study ID Numbers: 07455
Study First Received: February 28, 2008
Last Updated: April 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Hilar Cholangiocarcinoma (Klatskin Tumor)
External Beam Radiation
Cyberknife
Capecitabine

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin's Tumor
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014