Ireland
--:--IST
Active, not recruiting Not applicable

Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer

NCT03408665 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2019-03-13
Last updated
2026-03-30

Condition(s) studied

Liver CancerLiver Metastases

Investigational drug(s) / intervention(s)

SBRT

SBRT: 3 sessions at least, up to 6. Neither specifc device is imposed.

Study summary

Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years old * With primary or secondary liver tumor and matching one of the following situations: * Liver Metastasis (LM): anatomopathologic diagnosis of the primary tumor * Hepatocellular Carcinoma (HCC): diagnosis achieved through biopsy or through non-invasive methods approved by AASLD criteria (Bruix, 2011) * Cholangiocarcinoma (CC): diagnosis achieved through biopsy * Other primitive hepatic tumor achieved through biopsy * Meet the requirements for SBRT treatment: * Liver Metastasis (LM): oligometastatic disease * Hepatocellular Carcinoma (HCC): non eligible lesion to curative surgery * Cholangiocarcinoma (CC): nodular lesion * Other primitive hepatic tumor: non eligible lesion to curative surgery * Able to receive a SBRT treatment according to the multidisciplinary consultation meeting * Tumor assessable with CT-scan or MRI according to mRECIST in HCC or Recist 1.1 in other situations * Affiliation to the National Social Security System * With informed and signed consent Exclusion Criteria: * Eligibility to a curative surgery according to the multidisciplinary consultation meeting * Contraindication to SBRT (especially Cirrhose Child C) * Pregnant or breastfeeding women * Patient Under guardianship or tutorship * Impossibility to submit at the study procedures due to geographic, social or mental reasons

Primary outcome measure(s)

  • SBRT efficiency in term of L-PFS for patient who are to be treated with SBRT in patients with primitive hepatic tumor of hepatic metastatis — From baseline to 36 months following up.
    Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.

Trial sites (7)

FacilityCityRegionStatus
Centre Oscar Lambret Lille Nord
Centre Léonard de Vinci Dechy France
Institut Régional du Cancer de Montpellier Montpellier France
Institut de Cancérologie Paris Nord Sarcelles France
Centre Paul Strauss Strasbourg France
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France
Institut Gustave Roussy Villejuif France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03408665 on ClinicalTrials.gov ↗ ← All trials in France