Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
The purpose of this study is to determine the effects of CyberKnife stereotactic body radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal cancer that has spread to the liver.
Conventional radiation therapy has a limited role in the treatment of patients with liver metastases because the radiation doses are limited by liver toxicity. The CyberKnife system is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so that injury from radiation to the nearby normal tissue will be minimal. It is approved by the U.S. Food and Drug Administration to treat tumors, lesions and conditions anywhere in the body when radiation therapy is required. While the device is no longer classified as "investigational", the best treatment dose and times are still being evaluated.
Chemotherapy delivered with radiation therapy can increase the effectiveness of treatment, and may allow for a lower dose of radiation therapy to be utilized, thereby limiting negative side effects.
In this study, patients will receive Cyberknife radiosurgery directed to liver metastasis for 3-5 treatments, given every other day. Irinotecan 40mg/m2 will be administered intravenously daily for 3-5 days (5 treatments within 10 elapsed days), and prior to radiation therapy. Patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30, 36, and every 6 months thereafter for 3 years.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Evaluation of Low-dose Irinotecan and Cyberknife® Stereotactic Body Radiotherapy in the Treatment of Patients With Colorectal Cancer and Limited Liver Metastasis|
- Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Tumor response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||October 2025|
|Estimated Primary Completion Date:||October 2020 (Final data collection date for primary outcome measure)|
Experimental: Low-Dose Irinotecan & CyberKnife SBRT
Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions
40mg/m2 x 3-5 days
Other Names:Radiation: CyberKnife
45-60 Gy for 3-5 days CyberKnife SBRT to liver metastasis within 10 elapsed days. Irinotecan will be administered on the same day, prior to SBRT.
Other Name: Stereotactic Radiosurgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847495
|Contact: Arica Hirsch, MD||847 723-8030|
|United States, Illinois|
|Advocate Lutheran General Hospital||Recruiting|
|Park Ridge, Illinois, United States, 60068|
|Contact: Arica Hirsch, MD|
|Study Chair:||Arica Hirsch, MD||Advocate Lutheran General Hospital|
|Study Chair:||James Ruffer, MD||Advocate Lutheran General Hospital|
|Study Chair:||Jacob Bitran, MD||Advocate Lutheran General Hospital|
|Study Chair:||Edward S James, M.D.||Advocate Lutheran General Hospital|