NCT03408665

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Mar 2019Jan 2027

First Submitted

Initial submission to the registry

January 4, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 13, 2019

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

7.7 years

First QC Date

January 4, 2018

Last Update Submit

March 25, 2026

Conditions

Liver CancerLiver Metastases

Outcome Measures

Primary Outcomes (1)

  • 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.

    From baseline to 36 months following up.

Secondary Outcomes (12)

  • 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.

    From baseline to 36 months following up.

  • Describe the different SBRT techniques used in the study for liver tumor.

    From baseline to 36 months following up.

  • Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.

    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.

    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.

    From baseline to 36 months following up.

  • +7 more secondary outcomes

Study Arms (1)

SBRT

EXPERIMENTAL

Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.

Radiation: SBRT

Interventions

SBRTRADIATION

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

SBRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Oscar Lambret

Lille, Nord, 59020, France

Location

Centre Léonard de Vinci

Dechy, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, France

Location

Institut de Cancérologie Paris Nord

Sarcelles, 95200, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Xavier MIRABEL, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 24, 2018

Study Start

March 13, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)