NCT01318447

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Geographic Reach
3 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

March 16, 2011

Last Update Submit

April 5, 2013

Conditions

Colorectal Liver Metastases

Keywords

Hepatic metastasesLiver metastasesColorectal cancerColorectal adenocarcinomaAccurayCyberKnife

Outcome Measures

Primary Outcomes (1)

  • Local recurrence-free survival

    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.

    12 months

Secondary Outcomes (6)

  • Recurrence-free survival

    3, 6, 9, 12, 18 and 24 months

  • Overall survival

    3, 6, 9, 12, 18 and 24 months

  • Acute and long term toxicity

    3, 6, 9, 12, 18 and 24 months

  • Quality of Life

    3, 6, 9, 12, 18 and 24 months

  • 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)

    6, 18 and 24 months

  • +1 more secondary outcomes

Study Arms (1)

CyberKnife SBRT

EXPERIMENTAL
Radiation: CyberKnife SBRT

Interventions

CyberKnife SBRTRADIATION

Dose is 45 Gy (15 Gy in 3 fractions) and delivered over 5 to 10 days.

CyberKnife SBRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • Hepatic metastases from histologically confirmed colorectal adenocarcinoma
  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Antoine Lacassagne

Nice, France, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Alexis Vautrin Cancer Center

Nancy, France

Location

Hopital Bretonneau

Tours, France

Location

CyberKnife Zentrum Mecklenburg-Vorpommern

Güstrow, Germany, Germany

Location

Harley Street Clinic

London, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Xavier Mirabel, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 18, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

GB(1)FR(4)DE(1)