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

Primary Purpose

Liver Cancer, Liver Metastases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SBRT
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar LambretRecruiting
  • Centre Léonard de VinciRecruiting
  • Institut Régional du Cancer de MontpellierRecruiting
  • Centre Antoine Lacassagne
  • Institut de Cancérologie Lucien Neuwirth
  • Institut de Cancérologie Paris NordRecruiting
  • Centre Paul StraussRecruiting
  • Institut Claudius RegaudRecruiting
  • CHRU Tours - Hôpital Bretonneau
  • Institut de Cancérologie de LorraineRecruiting
  • Institut Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Describe the different SBRT techniques used in the study for liver tumor.
Description of SBRT techniques used.
Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.
Description of reasons leading to SBRT scheme modification or interruption.
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.
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.
Assess the immediate and delayed toxicity.
Description of toxicity associated to SBRT or the fiducial use thanks to NCI-CTCAE v4.0.
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.
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.
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.
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.
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.

Full Information

First Posted
January 4, 2018
Last Updated
February 7, 2023
Sponsor
Centre Oscar Lambret
Collaborators
Canceropôle Nord Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT03408665
Brief Title
Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer
Acronym
STEREOLIVER
Official Title
Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
March 13, 2026 (Anticipated)
Study Completion Date
March 13, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Canceropôle Nord Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Experimental
Arm Description
Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
3 sessions at least, up to 6. Neither specifc device is imposed.
Primary Outcome Measure Information:
Title
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
Description
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.
Secondary Outcome Measure Information:
Title
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.
Description
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.
Title
Describe the different SBRT techniques used in the study for liver tumor.
Description
Description of SBRT techniques used.
Time Frame
From baseline to 36 months following up.
Title
Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.
Description
Description of reasons leading to SBRT scheme modification or interruption.
Time Frame
From baseline to 36 months following up.
Title
Estimate the SBRT efficiency in a prospective way, in term of overall survival (OS) in the 4 considered clinical situations.
Description
Overall survivall thanks to Kaplan-meier method, from registration date to date of death.
Time Frame
From baseline to 36 months following up.
Title
Estimate the SBRT efficiency in a prospective way, in term of progression-free survival (PFS) in the 4 considered clinical situations.
Description
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.
Title
Assess the immediate and delayed toxicity.
Description
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.
Title
Estimate the quality-adjusted survival (Q-TWiST) for patients in each of the 4 considered clinical situations.
Description
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.
Title
Estimate the proportion of patients for whom an hospitalization is required.
Description
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.
Title
Estimate the impact of the different SBRT techniques on SBRT efficacy according to L-PFS.
Description
Estimation of impact of SBRT technique used on SBRT efficacy according to L-PFS.
Time Frame
From baseline to 36 months following up.
Title
Estimate the impact of the different SBRT techniques on SBRT efficacy according to PFS.
Description
Estimation of impact of SBRT technique used on SBRT efficacy according to PFS.
Time Frame
From baseline to 36 months following up.
Title
Estimate the impact of the different SBRT techniques on SBRT efficacy according to OS.
Description
Estimation of impact of SBRT technique used on SBRT efficacy according to OS.
Time Frame
From baseline to 36 months following up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien THERY
Phone
+33320295918
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier MIRABEL, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
State/Province
Nord
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier MIRABEL, MD
Phone
+33320295911
Email
x-mirabel@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Xavier MIRABEL, MD
First Name & Middle Initial & Last Name & Degree
Antoine CARLIER, MD
First Name & Middle Initial & Last Name & Degree
Florence LE TINIER, MD
First Name & Middle Initial & Last Name & Degree
Xavier LIEM, MD
First Name & Middle Initial & Last Name & Degree
David PASQUIER, MD
Facility Name
Centre Léonard de Vinci
City
Dechy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck DARLOY, MD
Phone
+33327086062
Email
fdarloy@clinique-psv.fr
First Name & Middle Initial & Last Name & Degree
Franck DARLOY, MD
First Name & Middle Initial & Last Name & Degree
Damien CARLIER, MD
First Name & Middle Initial & Last Name & Degree
Louis GRAS, MD
First Name & Middle Initial & Last Name & Degree
Lise UCLA, MD
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier RIOU, MD
Phone
+33467614737
Email
olivier.riou@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Olivier RIOU, MD
First Name & Middle Initial & Last Name & Degree
David AZRIA, PhD
First Name & Middle Initial & Last Name & Degree
Sylvain DEMONTOY, MD
First Name & Middle Initial & Last Name & Degree
Alexis LENGLET, MD
First Name & Middle Initial & Last Name & Degree
Carmen LLACER, MD
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Withdrawn
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MAGNE, PhD
Phone
+33477917434
Email
nicolas.magné@icloire.fr
First Name & Middle Initial & Last Name & Degree
Nicolas MAGNE, PhD
First Name & Middle Initial & Last Name & Degree
Amel REHALIA-BLANCHARD, MD
Facility Name
Institut de Cancérologie Paris Nord
City
Sarcelles
ZIP/Postal Code
95200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne LARROUY, MD
Email
a.larrouy@icpn.care
First Name & Middle Initial & Last Name & Degree
Anne LARROUY, MD
First Name & Middle Initial & Last Name & Degree
Julie GIROUX, MD
First Name & Middle Initial & Last Name & Degree
Guiilaume SERGENT, MD
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges NOEL, PhD
Phone
+33388252485
Email
gnoel@strasbourg.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Georges NOEL, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste CLAVIER, MD
First Name & Middle Initial & Last Name & Degree
Audrey KELLER, MD
First Name & Middle Initial & Last Name & Degree
Catherine SCHUMACHER, MD
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anouchka MODESTO, MD
Phone
+33 05.31.15.54.44
Email
modesto.anouchka@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Lekhal Amina BOUAMAMA, MD
Facility Name
CHRU Tours - Hôpital Bretonneau
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles CALAIS, PhD
Phone
+33247478265
Email
gilles.calais@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Gilles CALAIS, PhD
First Name & Middle Initial & Last Name & Degree
Sophie CHAPET, MD
First Name & Middle Initial & Last Name & Degree
Guillaume JANORAY, MD
First Name & Middle Initial & Last Name & Degree
Ossama DIDAS, MD
First Name & Middle Initial & Last Name & Degree
Aurélien ROBERT, MD
First Name & Middle Initial & Last Name & Degree
Alice THERON, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier PEIFFERT, PhD
Phone
+33383598431
Email
d.peiffert@nancy.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Didier PEIFFERT, PhD
First Name & Middle Initial & Last Name & Degree
Anne-Sophie BAUMANN, MD
First Name & Middle Initial & Last Name & Degree
Maria JOLNEROVSKI, MD
First Name & Middle Initial & Last Name & Degree
Paul JUNG, MD
First Name & Middle Initial & Last Name & Degree
Myriam KHADIGE, MD
First Name & Middle Initial & Last Name & Degree
Jean François PY, MD
First Name & Middle Initial & Last Name & Degree
Anaïs STEFANI, MD
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme DURAND-LABRUNIE, MD
Phone
01.42.11.42.11
Email
jerome.durand-labrunie@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Jérôme DURAND-LABRUNIE, MD
First Name & Middle Initial & Last Name & Degree
Valérie BOIGE, MD
First Name & Middle Initial & Last Name & Degree
Pascal BURTIN, MD
First Name & Middle Initial & Last Name & Degree
Michel DUCREUX, PhD
First Name & Middle Initial & Last Name & Degree
Alina FUEREA, MD
First Name & Middle Initial & Last Name & Degree
Antoine HOLLEBECQUE, MD
First Name & Middle Initial & Last Name & Degree
David MALKA, MD
First Name & Middle Initial & Last Name & Degree
Margarida MATIAS, MD
First Name & Middle Initial & Last Name & Degree
Eric DEUTSCH, PhD
First Name & Middle Initial & Last Name & Degree
Claire PETIT, MD
First Name & Middle Initial & Last Name & Degree
Caroline PRIEUX-KLOTZ, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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