NCT03408665

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

Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will first go through an inclusion check-up consisting of: * a clinical exam: disease history, previous treatments, weight, height, patient's performance status (ECOG) and HCC status. * a biological test: biochemical (total bilirubin, ASAT-ALAT, LDH, albumin, alkaline phosphatases, GGT), hematological (if the patient is going to receive a fiducial), alphafoetoprotein (for HCC) and pregnancy test (if applicable) * a tumor assessment: using a CT-scan or a MRI and using RECIST or mRECIST (if HCC), plus other morphological exams if judged useful by the investigator This check-up has to be realized within 28 days before inclusion. Then, the use of fiducial is optional. Before the beginning of the treatment, a pre-therapeutic check-up is done: * the inclusion check-up has to be done a second time if the treatment begins more than 28 days after the first one * Tracking scanner. 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.

Conditions

• Liver Cancer
• Liver Metastases

Interventions

Type	Name	Description
RADIATION	SBRT	3 sessions at least, up to 6. Neither specifc device is imposed.

Timeline

• Start date: 2019-03-13
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2018-01-24
• Last updated: 2026-03-30

Locations

7 sites across 1 country: France