- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847495
Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
Prospective Evaluation of Low-dose Irinotecan and Cyberknife® Stereotactic Body Radiotherapy in the Treatment of Patients With Colorectal Cancer and 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Park Ridge, Illinois, United States, 60068
- Advocate Lutheran General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 3 years
|
3 years
|
Progression free survival
Time Frame: 3 years
|
3 years
|
Tumor response rate
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 5443
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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