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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01847495
• Other study ID #: 5443
• Status: Withdrawn
• Phase: N/A
• Start date: October 2013
• Est. completion date: November 29, 2017

Study information

• Verified date: July 2021
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Irinotecan
40mg/m2 x 3-5 days

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.

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan		3 years
Secondary	Tumor response rate		3 years
Secondary	Progression free survival		3 years
Secondary	Overall survival		3 years