CyberKnife® for Hepatic Metastases From Colorectal Cancer

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
Centre Oscar Lambret
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT01318447
First received: March 16, 2011
Last updated: April 5, 2013
Last verified: April 2013
  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:


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.


Enrollment: 15
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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.

  Show Detailed Description

  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
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: NCT01318447

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Alexis Vautrin Cancer Center
Nancy, France
Centre Antoine Lacassagne
Nice, France
Hopital Bretonneau
Tours, France
Germany
CyberKnife Zentrum Mecklenburg-Vorpommern
Gustrow, Germany
United Kingdom
Harley Street Clinic
London, United Kingdom
Sponsors and Collaborators
Accuray Incorporated
Centre Oscar Lambret
Investigators
Principal Investigator: Xavier Mirabel, MD Centre Oscar Lambret
  More Information

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: April 5, 2013
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 August 28, 2014