CyberKnife® for Hepatic Metastases From Colorectal Cancer - Full Text View

Sponsor:	Accuray Incorporated
Collaborator:	Centre Oscar Lambret
Information provided by (Responsible Party):	Accuray Incorporated
ClinicalTrials.gov Identifier:	NCT01318447

Purpose

This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.

Condition	Intervention	Phase
Colorectal Liver Metastases	Radiation: CyberKnife SBRT	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	International, Phase II Study of CyberKnife® for Hepatic Metastases From Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:

Local recurrence-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Local hepatic control (non progression: complete response, partial response or stable disease) will be assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Local recurrence-free survival time is calculated as the time between the date of first treatment session and the date of the first local recurrence. Patients alive who never experienced local recurrence at the time of analysis are censored at the date of the last follow-up visit. Patients who die from causes other than local recurrence at the time of analysis are censored at the date of death.

Secondary Outcome Measures:

Recurrence-free survival [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
Recurrence-free survival time is calculated as the time between the date of first treatment session and the date of a local or distant recurrence or death from progression whichever comes first. Patients alive who never experienced recurrence at the time of analysis are censored at the date of the last follow-up visit. Patients who die from causes other than cancer are censored at the date of death.
Overall survival [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
Overall survival time is calculated as the time between the date of first treatment session and the date of death, whatever the cause. Patients alive at the time of analysis are censored at the date of the last follow-up visit.
Acute and long term toxicity [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for toxicity assessment.
Quality of Life [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) measures the quality of life for patients with cancer (for all participating sites).
- Quality of Life Questionnaire-Liver Metastases Colorectal (QLQ-LMC21) is a specific module developed by the EORTC for patients with colorectal liver metastases (for sites in the United Kingdom, The Netherlands, Germany, France, and Belgium (French speaking part)).
Correlation of response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST) [ Time Frame: 6, 18 and 24 months ] [ Designated as safety issue: No ]
The PERCIST response criteria will be applied to patients who have tumor characteristics measured by a PET-Scan. The association of response according to RECIST 1.1 and PERCIST will be evaluated with Spearman's correlation coefficient and the kappa statistic.
Local recurrence-free survival [ Time Frame: 3, 6, 9, 18 and 24 months ] [ Designated as safety issue: No ]
Local hepatic control (non progression: complete response, partial response or stable disease) will be assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Local recurrence-free survival time is calculated as the time between the date of first treatment session and the date of the first local recurrence. Patients alive who never experienced local recurrence at the time of analysis are censored at the date of the last follow-up visit. Patients who die from causes other than local recurrence at the time of analysis are censored at the date of death.

Estimated Enrollment:	72
Study Start Date:	January 2011
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CyberKnife SBRT	Radiation: CyberKnife SBRT Dose is 45 Gy (15 Gy in 3 fractions) and delivered over 5 to 10 days.

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Eligibility

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

Criteria

Inclusion Criteria:

Male or Female
Hepatic metastases from histologically confirmed colorectal adenocarcinoma
3 hepatic lesions or less present
Cumulative size of hepatic lesions between 1 and 10 cm
Treatment determined by the liver/GI tumor board or equivalent organization at the participating site
Metastatic disease not amenable to surgery as assessed by the panel (including a surgeon) or patient who refuses surgery
Patient must be able to undergo contrast enhanced CT for planning
Age >= 18 years old
Performance Status (ECOG) ≤ 2
Minimum of 6 months between the initial diagnosis of the disease and the first hepatic metastasis
Minimum of 4 weeks between prior chemotherapy or targeted therapy and the first CyberKnife session
Total bilirubin ≤ 3 times the upper limit of normal, ASAT and ALAT ≤ 5 times the upper limit of normal
Albumin >= 36 g/L and lymphocytes >= 700/mm3
No contraindication to fiducials implantation, hemostasis problems shall be corrected before implantation
Life expectancy >= 3 months
Patient affiliated with a health insurance system. Applicable for French patients only.
Patient having signed the informed consent

Exclusion Criteria:

Prior abdominal radiation therapy
Any evidence of visible intra-hepatic bile duct dilatation on pre-treatment images
Extrahepatic metastases
Current evidence of ascitis
Renal insufficiency (creatinine clearance < 45 ml/min)
Known allergy to gold
Pregnant or lactating woman
Prior history of other cancer except basocellular carcinoma and in situ cervix carcinoma
Patient already enrolled in another therapeutic clinical trial
Inability to comply with follow-up visits for geographical, social or psychological reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318447

Contacts

Contact: Jan Jenkins	(408) 338-9372	jjenkins@accuray.com
Contact: Omar Dawood, MD, MPH	408.789.4457	odawood@accuray.com

Locations

United States, Montana
Sletten Cancer Institute	Not yet recruiting
Great Falls, Montana, United States, 59405
Principal Investigator: Kelly J Underhill
United States, Washington
Multicare Research Institute	Not yet recruiting
Tacoma, Washington, United States, 98405
Contact: Samantha Elliott, P 253-403-2319 samantha.elliott@multicare.org
Contact: Richard Shine, Pharm D 253-403-7250 richard.shine@multicare.org
Principal Investigator: John Rieke
Canada, Ontario
The Ottawa Hospital Cancer Centre	Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Valerie Bourada 613-737-7700 ext 73328 vbourada@ohri.ca
Principal Investigator: Jason R Pantarotto
France
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Principal Investigator: Xavier Mirabel
Alexis Vautrin Cancer Center	Recruiting
Nancy, France
Hopital Bretonneau	Recruiting
Tours, France

Sponsors and Collaborators

Accuray Incorporated

Centre Oscar Lambret

Investigators

Principal Investigator:

Xavier Mirabel, MD

Centre Oscar Lambret

More Information

Additional Information:

Information on CyberKnife This link exits the ClinicalTrials.gov site

Sponsor website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Accuray Incorporated
ClinicalTrials.gov Identifier:	NCT01318447 History of Changes
Other Study ID Numbers:	ACC-HM-001
Study First Received:	March 16, 2011
Last Updated:	February 23, 2012
Health Authority:	France: Institutional Ethical Committee United States: Institutional Review Board

Keywords provided by Accuray Incorporated:

Hepatic metastases
Liver metastases
Colorectal cancer

Colorectal adenocarcinoma
Accuray
CyberKnife

Additional relevant MeSH terms:

Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2012