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• Status: Withdrawn
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Irinotecan; Radiation: CyberKnife

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

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	Drug: Irinotecan; 40mg/m2 x 3-5 days; Other Names: Camptosar; CPT-11; Irinotecan Hydrochloride; Irinotecan HCl; 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 Names: Stereotactic Radiosurgery

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	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	3 years
Progression free survival	3 years
Tumor response rate	3 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• 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: October 1, 2013
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: April 12, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimated): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: SBRT; Stereotactic Body Radiotherapy; CPT-11; Liver metastasis; Cyberknife; Stage IV Colorectal Carcinoma; Irinotecan HCl
• 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