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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Advocate Health Care
Information provided by (Responsible Party):
Arica Hirsch, MD, Advocate Health Care
ClinicalTrials.gov Identifier:
First received: April 12, 2013
Last updated: September 17, 2015
Last verified: September 2015

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.

Condition Intervention
Colorectal Cancer
Drug: Irinotecan
Radiation: CyberKnife

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Advocate Health Care:

Primary Outcome Measures:
  • Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: October 2013
Estimated Study Completion Date: October 2025
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Irinotecan Hydrochloride
  • Irinotecan HCl
  • CPT-11
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 Name: Stereotactic Radiosurgery


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847495

Contact: Arica Hirsch, MD 847 723-8030

United States, Illinois
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Arica Hirsch, MD         
Sponsors and Collaborators
Advocate Health Care
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
  More Information

No publications provided

Responsible Party: Arica Hirsch, MD, Principal Investigator, Advocate Health Care
ClinicalTrials.gov Identifier: NCT01847495     History of Changes
Other Study ID Numbers: 5443
Study First Received: April 12, 2013
Last Updated: September 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Advocate Health Care:
Stage IV Colorectal Carcinoma
Liver metastasis
Stereotactic Body Radiotherapy
Irinotecan HCl

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 09, 2015