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Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fiducials
CyberKnife
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver cancer, hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primitive liver cancer (hepatocellular carcinoma), proved by histology or diagnostic according to BCLC criteria
  • T1-3 N0 M0
  • With only one intra hepatic lesion and dimensions between 1 cm and 6 cm (IRM or hepatic scanner)
  • Stereotaxic radiotherapy treatment approved in multidisciplinary consultation, the patient being rejected for standard therapeutic
  • Age >= 18 ans
  • Previous anti tumoral treatment allowed but suspended since at least 15 days before the inclusion
  • OMS =< 2
  • Portal thrombosis allowed
  • Portal high blood pressure allowed
  • No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
  • In case of underlying cirrhosis, only the Child-Pugh A is allowed
  • Life expectancy >= 12 weeks
  • Women must have an active contraception during all the study
  • Patient affiliated to health insurance
  • Patient must sign the consent

Exclusion Criteria:

  • T4
  • Cirrhosis Child B and C
  • Hepatic lesion < 1 cm or > 6 cm
  • 2 hepatic lesions or more
  • Recurrent or metastatic disease
  • Patient already included in another therapeutic trial with an experimental molecule
  • Allergy to gold
  • Pregnant women or susceptible to be pregnant or breastfeeding
  • Unable for medical follow-up (geographic, social or mental reasons)

Sites / Locations

  • Centre François Baclesse
  • Centre Oscar LAMBRET
  • Centre Léon Bérard
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotaxic radiation by CyberKnife

Arm Description

Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days

Outcomes

Primary Outcome Measures

non-progression part
Percentage of non-progression 18 months after treatment, according to RECIST criteria

Secondary Outcome Measures

acute and late tolerance
Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria.
hepatic non progression part
Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.
median time without progression
Time between : Date of inclusion Date of progression
Best response
determination of the best response of treatment, according to RECIST
tumor evaluation
According to EASL
Quality of life
Questionnaire EORTC QLQ-C30 and QLQ-HCC18
Biological response
tumoral marker : Alpha-fetoprotein
Medical costs
micro-costing

Full Information

First Posted
July 16, 2010
Last Updated
May 13, 2019
Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT01165346
Brief Title
Stereotaxic Irradiation of Hepatocellular Carcinoma
Acronym
CKNO-HEP
Official Title
Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2009 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
April 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
Detailed Description
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
liver cancer, hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotaxic radiation by CyberKnife
Arm Type
Experimental
Arm Description
Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
Intervention Type
Radiation
Intervention Name(s)
Fiducials
Intervention Description
Implantation of fiducials
Intervention Type
Radiation
Intervention Name(s)
CyberKnife
Intervention Description
3 fractions over 8 to 10 days, 15 Gy/fraction
Primary Outcome Measure Information:
Title
non-progression part
Description
Percentage of non-progression 18 months after treatment, according to RECIST criteria
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
acute and late tolerance
Description
Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria.
Time Frame
Up to 5 years after treatment
Title
hepatic non progression part
Description
Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.
Time Frame
Up to 3, 6, 9, 12 months
Title
median time without progression
Description
Time between : Date of inclusion Date of progression
Time Frame
Up to 5 years after treatment
Title
Best response
Description
determination of the best response of treatment, according to RECIST
Time Frame
Up to 5 years after treatment
Title
tumor evaluation
Description
According to EASL
Time Frame
Up to 5 years after treatment
Title
Quality of life
Description
Questionnaire EORTC QLQ-C30 and QLQ-HCC18
Time Frame
Up to 18 months after treatment
Title
Biological response
Description
tumoral marker : Alpha-fetoprotein
Time Frame
Up to 3, 6, 9 months
Title
Medical costs
Description
micro-costing
Time Frame
During the first 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primitive liver cancer (hepatocellular carcinoma), proved by histology or diagnostic according to BCLC criteria T1-3 N0 M0 With only one intra hepatic lesion and dimensions between 1 cm and 6 cm (IRM or hepatic scanner) Stereotaxic radiotherapy treatment approved in multidisciplinary consultation, the patient being rejected for standard therapeutic Age >= 18 ans Previous anti tumoral treatment allowed but suspended since at least 15 days before the inclusion OMS =< 2 Portal thrombosis allowed Portal high blood pressure allowed No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation In case of underlying cirrhosis, only the Child-Pugh A is allowed Life expectancy >= 12 weeks Women must have an active contraception during all the study Patient affiliated to health insurance Patient must sign the consent Exclusion Criteria: T4 Cirrhosis Child B and C Hepatic lesion < 1 cm or > 6 cm 2 hepatic lesions or more Recurrent or metastatic disease Patient already included in another therapeutic trial with an experimental molecule Allergy to gold Pregnant women or susceptible to be pregnant or breastfeeding Unable for medical follow-up (geographic, social or mental reasons)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier MIRABEL, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Oscar LAMBRET
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Stereotaxic Irradiation of Hepatocellular Carcinoma

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