Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

NCT00630890 | Terminated Phase 1

• 1 other identifier: 07455
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma; Klatskin Tumor; Biliary Tract Cancer

Keywords

Hilar Cholangiocarcinoma (Klatskin Tumor); External Beam Radiation; Cyberknife; Capecitabine

Outcome Measures

Primary Outcomes (2)

• To evaluate acute toxicities

  3 months for acute toxicities

• To determine the maximal tolerated dose of the Cyberknife radiosurgery boost

  3 months for acute toxicities

Secondary Outcomes (4)

• To assess local and regional control

  two years

• To evaluate radiographic response

  two years

• To assess delayed and long-term toxicities

  two years

• To estimate disease specific and overall survival

  two years

Study Arms (1)

1

EXPERIMENTAL

External beam radiation with Cyberknife radiosurgery boost and concurrent capecitabine

Radiation: External beam radiation and Cyberknife radiosurgery boost and capecitabine

Interventions

External beam radiation and Cyberknife radiosurgery boost and capecitabine RADIATION

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

Also known as: Xeloda

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143-0226, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Klatskin Tumor; Biliary Tract Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Kim Huang, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 11, 2015

Record last verified: 2015-09

Locations

US (1)