Stereotaxic Irradiation of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— CKNO-HEP  

Official title:

Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165346
• Other study ID #: CKNO-HEP-0703
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2009
• Est. completion date: April 19, 2018

Study information

• Verified date: May 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 19, 2018
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Fiducials
Implantation of fiducials
• CyberKnife
3 fractions over 8 to 10 days, 15 Gy/fraction

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Oscar LAMBRET	Lille
France	Centre Léon Bérard	Lyon
France	Centre Alexis Vautrin	Vandoeuvre Les Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-progression part	Percentage of non-progression 18 months after treatment, according to RECIST criteria	Up to 18 months
Secondary	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.	Up to 5 years after treatment
Secondary	hepatic non progression part	Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.	Up to 3, 6, 9, 12 months
Secondary	median time without progression	Time between : Date of inclusion; Date of progression	Up to 5 years after treatment
Secondary	Best response	determination of the best response of treatment, according to RECIST	Up to 5 years after treatment
Secondary	tumor evaluation	According to EASL	Up to 5 years after treatment
Secondary	Quality of life	Questionnaire EORTC QLQ-C30 and QLQ-HCC18	Up to 18 months after treatment
Secondary	Biological response	tumoral marker : Alpha-fetoprotein	Up to 3, 6, 9 months
Secondary	Medical costs	micro-costing	During the first 3 months