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

NCT ID: NCT03408665

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2027-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT

Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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

Interventions

SBRT

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canceropôle Nord Ouest

OTHER

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier MIRABEL, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Centre Oscar Lambret

Lille, Nord, France

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

Countries

France

Other Identifiers

STEREOLIVER-1704

Identifier Type: -

Identifier Source: org_study_id