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

Last updated: February 11, 2025
Sponsor: Centre Oscar Lambret
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Liver Cancer

Liver Disease

Treatment

SBRT

Clinical Study ID

NCT03408665
STEREOLIVER-1704
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 throughnon-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 consultationmeeting

  • Tumor assessable with CT-scan or MRI according to mRECIST in HCC or Recist 1.1 inother situations

  • Affiliation to the National Social Security System

  • With informed and signed consent

Exclusion

Exclusion Criteria:

  • Eligibility to a curative surgery according to the multidisciplinary consultationmeeting

  • 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 mentalreasons

Study Design

Total Participants: 280
Treatment Group(s): 1
Primary Treatment: SBRT
Phase:
Study Start date:
March 13, 2019
Estimated Completion Date:
December 01, 2027

Study 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.

Connect with a study center

  • Centre Oscar Lambret

    Lille, Nord 59020
    France

    Site Not Available

  • Centre Léonard de Vinci

    Dechy,
    France

    Site Not Available

  • Institut Régional du Cancer de Montpellier

    Montpellier,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez,
    France

    Site Not Available

  • Institut de Cancérologie Paris Nord

    Sarcelles, 95200
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg,
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • CHRU Tours - Hôpital Bretonneau

    Tours,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.