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Completed

NCT Number: NCT01165346

Stereotaxic Irradiation of Hepatocellular Carcinoma

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre François Baclesse, Caen, France

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About this study

Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fiducials

Radiation

Implantation of fiducials

Cyberknife

Radiation

3 fractions over 8 to 10 days, 15 Gy/fraction

Primary outcomes

  1. non-progression part

    Time frame: Up to 18 months

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

Secondary outcomes

  1. acute and late tolerance

    Time frame: Up to 5 years after treatment

    Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria.

  2. hepatic non progression part

    Time frame: Up to 3, 6, 9, 12 months

    Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.

  3. median time without progression

    Time frame: Up to 5 years after treatment

    Time between :

    • Date of inclusion
    • Date of progression

  4. Best response

    Time frame: Up to 5 years after treatment

    determination of the best response of treatment, according to RECIST

  5. tumor evaluation

    Time frame: Up to 5 years after treatment

    According to EASL

  6. Quality of life

    Time frame: Up to 18 months after treatment

    Questionnaire EORTC QLQ-C30 and QLQ-HCC18

  7. Biological response

    Time frame: Up to 3, 6, 9 months

    tumoral marker : Alpha-fetoprotein

  8. Medical costs

    Time frame: During the first 3 months

    micro-costing

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

Acronym: CKNO-HEP

Important dates

Study start
2009
Primary completion
2016
Study completion
2018
First posted
Jul 19, 2010
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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