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

NCT01847495 | Withdrawn DMC

• 1 other identifier: 5443
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan

  3 years

Secondary Outcomes (3)

• Tumor response rate

  3 years

• Progression free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

Low-Dose Irinotecan & CyberKnife SBRT

EXPERIMENTAL

Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions

Drug: Irinotecan; Radiation: CyberKnife

Interventions

Irinotecan DRUG

40mg/m2 x 3-5 days

Also known as: Camptosar, Irinotecan Hydrochloride, Irinotecan HCl, CPT-11

Low-Dose Irinotecan & CyberKnife SBRT

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.

Also known as: Stereotactic Radiosurgery

Low-Dose Irinotecan & CyberKnife SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Radiosurgery

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: May 7, 2013
• Study Start: October 1, 2013
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: October 4, 2024

Record last verified: 2021-07

Locations

US (1)