Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irinotecan
CyberKnife
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Stage IV Colorectal Carcinoma, Liver metastasis, Cyberknife, Stereotactic Body Radiotherapy, SBRT, Irinotecan HCl, CPT-11
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.
Sites / Locations
- Advocate Lutheran General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-Dose Irinotecan & CyberKnife SBRT
Arm Description
Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions
Outcomes
Primary Outcome Measures
Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan
Secondary Outcome Measures
Tumor response rate
Progression free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847495
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no patients enrolled
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Stage IV Colorectal Carcinoma, Liver metastasis, Cyberknife, Stereotactic Body Radiotherapy, SBRT, Irinotecan HCl, CPT-11
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Dose Irinotecan & CyberKnife SBRT
Arm Type
Experimental
Arm Description
Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar, Irinotecan Hydrochloride, Irinotecan HCl, CPT-11
Intervention Description
40mg/m2 x 3-5 days
Intervention Type
Radiation
Intervention Name(s)
CyberKnife
Other Intervention Name(s)
Stereotactic Radiosurgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Tumor response rate
Time Frame
3 years
Title
Progression free survival
Time Frame
3 years
Title
Overall survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arica Hirsch, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James Ruffer, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacob Bitran, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edward S James, M.D.
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
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