Colorectal Cancer
Conditions
Keywords
Stage IV Colorectal Carcinoma, Liver metastasis, Cyberknife, Stereotactic Body Radiotherapy, SBRT, Irinotecan HCl, CPT-11
Brief summary
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.
Interventions
DRUGIrinotecan
40mg/m2 x 3-5 days
RADIATIONCyberKnife
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 years * Histologically confirmed primary colorectal cancer * Stage IV colorectal cancer with \</= 3 metastases, up to 5cm in size. * CT scan or MRI of the abdomen with contrast, 60days prior to enrollment * If patient is allergic to contrast, imaging without contrast is acceptable * Positron-Emission Tomography 60 days prior to enrollment * No additional sites of metastasis at the time of protocol enrollment. History of other sites of metastasis that are currently controlled are acceptable. * No malignant ascites * At least 4 weeks from any chemotherapy * No prior liver radiation therapy * ECOG performance status 0-1 * Life expectancy\>3months * Laboratory evaluations completed 60 days prior to treatment including CMP, CBC with differential, liver function test, and prothrombin time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | 3 years |
| Overall survival | 3 years |
| Tumor response rate | 3 years |
Countries
United States
Outcome results
None listed