An interventional study of SBRT in Liver Cancer and Liver Metastases, sponsored by Centre Oscar Lambret. Active, not recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Treatment
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.
Patients will first go through an inclusion check-up consisting of:
Before the beginning of the treatment, a pre-therapeutic check-up is done:
The SBRT treatment is done in 3 to 6 times and no specific SBRT techniques are asked for, the investigator can choose according to the center habits.
After the treatment, a follow-up will be realized at 3, 6, 9, 12, 18, 24, 30 and 36 months and then once a year until the last patient included reach their 36th month of follow-up. The follow-up check-up consists of a clinical exam, biological test, tumor assessment and tolerance assessment.
Exclusion Criteria:
Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.
Radiation: SBRT
3 sessions at least, up to 6. Neither specifc device is imposed.
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
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
Time frame: From baseline to 36 months following up.
Estimate the SBRT efficiency in a prospective way, in term of local progression-free survival (L-PFS) for patient treated with SBRT in the 4 considered clinical situations.
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
Time frame: From baseline to 36 months following up.
Describe the different SBRT techniques used in the study for liver tumor.
Description of SBRT techniques used.
Time frame: From baseline to 36 months following up.
Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.
Description of reasons leading to SBRT scheme modification or interruption.
Time frame: From baseline to 36 months following up.
Estimate the SBRT efficiency in a prospective way, in term of overall survival (OS) in the 4 considered clinical situations.
Overall survivall thanks to Kaplan-meier method, from registration date to date of death.
Time frame: From baseline to 36 months following up.
Estimate the SBRT efficiency in a prospective way, in term of progression-free survival (PFS) in the 4 considered clinical situations.
Progression-free survival (PFS) thanks to Kaplan-Meier method from registration date to date of progressive disease.
Time frame: From baseline to 36 months following up.
Assess the immediate and delayed toxicity.
Description of toxicity associated to SBRT or the fiducial use thanks to NCI-CTCAE v4.0.
Time frame: From baseline to 36 months following up.
Estimate the quality-adjusted survival (Q-TWiST) for patients in each of the 4 considered clinical situations.
Q-TWIST consists in 3 clinical states: time in toxicity before progressive disease, time in progressive disease, time without toxicity nor progressive disease.
Time frame: From baseline to 36 months following up.
Estimate the proportion of patients for whom an hospitalization is required.
during the treatment and until 3 months after and the cumulative duration of the hospitalization over those 3 months.
Time frame: From baseline to 36 months following up.
Estimate the impact of the different SBRT techniques on SBRT efficacy according to L-PFS.
Estimation of impact of SBRT technique used on SBRT efficacy according to L-PFS.
Time frame: From baseline to 36 months following up.
Estimate the impact of the different SBRT techniques on SBRT efficacy according to PFS.
Estimation of impact of SBRT technique used on SBRT efficacy according to PFS.
Time frame: From baseline to 36 months following up.
Estimate the impact of the different SBRT techniques on SBRT efficacy according to OS.
Estimation of impact of SBRT technique used on SBRT efficacy according to OS.
Time frame: From baseline to 36 months following up.
Quality of life according to QLQ-C30 questionnaire
QLQ-C30 will be filled at baseline, at the 3-months follow-up and at the 6-months follow-up.
Time frame: From Baseline to the 6-months follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Oscar Lambret