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

Part of paid clinical trials in Park Ridge, Illinois.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT01847495
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    40mg/m2 x 3-5 days
  • CyberKnife — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
Jul 2021
Primary completion
Nov 29, 2017
Completion
Nov 29, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Dose Irinotecan & CyberKnife SBRT
    Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions

Primary Outcome Measure

Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Advocate Lutheran General HospitalPark RidgeIllinois60068-

Find similar trials in Park Ridge, IL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Advocate Lutheran General Hospital· Park Ridge, IL

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