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 October 2013 by Advocate Health Care
Sponsor:
Information provided by (Responsible Party):
Arica Hirsch, MD, Advocate Health Care
ClinicalTrials.gov Identifier:
NCT01847495
First received: April 12, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 treatments, given every other day. Irinotecan chemotherapy injections will be given before radiation therapy (on the same day), for a total of 3 treatments Patients will have follow-up visits at weeks 3,6,9,13,17,21,25,37,and every 3 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 2023
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Dose Irinotecan & CyberKnife SBRT
Irinotecan 40mg/m2 x 3 days + CyberKnife SBRT 18Gy x 3 (54Gy)
Drug: Irinotecan
40mg/m2 x 3 days
Other Names:
  • Camptosar
  • Irinotecan Hydrochloride
  • Irinotecan HCl
  • CPT-11
Radiation: CyberKnife
18 Gy x 3(54Gy) CyberKnife SBRT to liver metastasis within 8 elapsed days. Irinotecan will be administered on the same day, prior to SBRT.
Other Name: Stereotactic Radiosurgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be ≥ 18 years of age.
  • Histologically proven primary colorectal carcinoma
  • Patient is clinical stage IV (AJCC 7th Edition)
  • Patient exhibits 1-4 liver metastasis
  • Liver is only site of metastasis
  • Chemotherapy administered prior to enrollment
  • Life expectancy > 3 months
  • At least 4 weeks from any chemotherapy
  • CBC, platelets, LFTs, PTT all within normal institutional limits
  • Patient's albumin level is >3gm/dl.
  • Negative pregnancy test within 72 hours of study entry for women of childbearing potential
  • ECOG performance status 0-1

Exclusion Criteria:

  • Prior radiotherapy to the liver
  • Hepato renal syndrome
  • Malignant ascites
  • Chemotherapy for a malignancy in the last 5 years
  • Inflammatory Bowel disease
  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

Contacts
Contact: Arica Hirsch, MD 847 723-8030

Locations
United States, Illinois
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Arica Hirsch, MD         
Sponsors and Collaborators
Advocate Health Care
Investigators
Study Chair: Arica Hirsch, MD Advocate Lutheran General Hospital
Study Chair: Tanya M. Powell, 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: Anthony Simon, MS, CMP Illinois CyberKnife
  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: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Advocate Health Care:
Stage IV Colorectal Carcinoma
Liver metastasis
Cyberknife
Stereotactic Body Radiotherapy
SBRT
Irinotecan HCl
CPT-11

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

ClinicalTrials.gov processed this record on October 02, 2014