Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)
This study is currently recruiting participants.
Verified May 2012 by Centre Oscar Lambret
Sponsor:
Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01165346
First received: July 16, 2010
Last updated: May 9, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Radiation: Fiducials Radiation: CyberKnife |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study |
Resource links provided by NLM:
Further study details as provided by Centre Oscar Lambret:
Primary Outcome Measures:
- non-progression part [ Time Frame: 18 months after treatment ] [ Designated as safety issue: No ]Percentage of non-progression 18 months after treatment, according to RECIST criteria
Secondary Outcome Measures:
- acute and late tolerance [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: Yes ]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 [ Time Frame: at 3, 6, 9, 12 months of treatment ] [ Designated as safety issue: No ]Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.
- median time without progression [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]
Time between :
- Date of inclusion
- Date of progression
- Best response [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]determination of the best response of treatment, according to RECIST
- tumor evaluation [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]According to EASL
- Quality of life [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]Questionnaire EORTC QLQ-C30 and QLQ-HCC18
- Biological response [ Time Frame: At 3, 6, 9 months after treatment ] [ Designated as safety issue: No ]tumoral marker : Alpha-fetoprotein
- Medical costs [ Time Frame: During the first 3 months ] [ Designated as safety issue: No ]micro-costing
| Estimated Enrollment: | 44 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Radiation: Fiducials
Implantation of fiducials
Radiation: CyberKnife
3 fractions over 8 to 10 days, 15 Gy/fraction
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165346
Contacts
| Contact: Xavier MIRABEL, MD | 03 20 29 55 98 | x-mirabel@o-lambret.fr |
| Contact: Yvette VENDEL, CRA | 03 20 29 59 40 | y-vendel@o-lambret.fr |
Locations
| France | |
| Centre Oscar LAMBRET | Recruiting |
| Lille, France, 59020 | |
| Contact: Xavier MIRABEL, MD 03 20 29 59 18 x-mirabel@o-lambret.fr | |
| Sub-Investigator: Eric LARTIGAU, PhD | |
| Sub-Investigator: Antoine ADENIS, PhD | |
| Sub-Investigator: Sophie DOMINGUEZ, MD | |
| Sub-Investigator: Thomas LACORNERIE | |
| Sub-Investigator: Thierry SARRAZIN | |
| Principal Investigator: Xavier MIRABEL, MD | |
| Sub-Investigator: Sylvain DEWAS, MD | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Christian CARRIE, MD 04 78 78 26 52 carrie@lyon.fnclcc.fr | |
| Principal Investigator: Christian CARRIE, MD | |
| Sub-Investigator: Isabelle MARTEL-LAFAY, MD | |
| Sub-Investigator: Séverine RACADOT, MD | |
| Sub-Investigator: Line CLAUDE, MD | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06182 | |
| Contact: Pierre-Yves BONDIAU, MD 04 92 03 16 51 pierre-yves.bondiau@nice.fnclcc.fr | |
| Sub-Investigator: Philippe FOLLANA, MD | |
| Sub-Investigator: Eric FRANCOIS, MD | |
| Sub-Investigator: Gaëlle ANGELLIER | |
| Sub-Investigator: Serge MARCIE | |
| Sub-Investigator: Juliette THARIAT, MD | |
| Principal Investigator: Pierre-Yves BONDIAU, MD | |
| Centre Alexis Vautrin | Recruiting |
| Vandoeuvre Les Nancy, France, 54500 | |
| Contact: Didier PEIFFERT, PhD 03 83 59 84 31 d.peiffert@nancy.fnclcc.fr | |
| Sub-Investigator: BECKENDORF Véronique, MD | |
| Sub-Investigator: Alain NOEL | |
| Sub-Investigator: Vincent MARCHESI | |
| Principal Investigator: Didier PEIFFERT, MD ,PhD | |
Sponsors and Collaborators
Centre Oscar Lambret
More Information
No publications provided
| Responsible Party: | Centre Oscar Lambret |
| ClinicalTrials.gov Identifier: | NCT01165346 History of Changes |
| Other Study ID Numbers: | CKNO-HEP-0703 |
| Study First Received: | July 16, 2010 |
| Last Updated: | May 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Oscar Lambret:
|
liver cancer hepatocellular carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013