Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Drug: Irinotecan; Radiation: CyberKnife

• Registration Number: NCT01847495
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Study Start: 2013-10
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Status Verified: 2021-07
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-Dose Irinotecan & CyberKnife SBRT	CyberKnife	Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions
Low-Dose Irinotecan & CyberKnife SBRT	Irinotecan	Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan	3 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival	3 years
Tumor response rate	3 years
Overall survival	3 years

Trial Locations

Locations (1)

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States