Clinical trial NCT01847495: Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Stage IV Colorectal Carcinoma
Liver metastasis
Cyberknife
Stereotactic Body Radiotherapy
SBRT
Irinotecan HCl
CPT-11
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan
timeFrame: 3 years
Secondary outcomes:
measure: Tumor response rate
timeFrame: 3 years
measure: Progression free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Advocate Lutheran General Hospital
name: Arica Hirsch, MD
role: STUDY_CHAIR
affiliation: Advocate Lutheran General Hospital
name: James Ruffer, MD
role: STUDY_CHAIR
affiliation: Advocate Lutheran General Hospital
name: Jacob Bitran, MD
role: STUDY_CHAIR
affiliation: Advocate Lutheran General Hospital
name: Edward S James, M.D.
role: STUDY_CHAIR
References: