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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Metastases; Liver Cancer
• Intervention / Treatment: Radiation: SBRT

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dechy, France
    • Centre Leonard de Vinci
  • Montpellier, France
    • Institut Regional du Cancer de Montpellier
  • Sarcelles, France, 95200
    • Institut de Cancerologie Paris Nord
  • Strasbourg, France
    • Centre Paul Strauss
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94800
    • Institut Gustave Roussy
  • Nord
    • Lille, Nord, France, 59020
      • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT; Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.	Radiation: SBRT; 3 sessions at least, up to 6. Neither specifc device is imposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 36 months following up.
Describe the different SBRT techniques used in the study for liver tumor.	Description of SBRT techniques used.	From baseline to 36 months following up.
Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.	Description of reasons leading to SBRT scheme modification or interruption.	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.	Overall survivall thanks to Kaplan-meier method, from registration date to date of death.	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.	Progression-free survival (PFS) thanks to Kaplan-Meier method from registration date to date of progressive disease.	From baseline to 36 months following up.
Assess the immediate and delayed toxicity.	Description of toxicity associated to SBRT or the fiducial use thanks to NCI-CTCAE v4.0.	From baseline to 36 months following up.
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.	From baseline to 36 months following up.
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.	From baseline to 36 months following up.
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.	From baseline to 36 months following up.
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.	From baseline to 36 months following up.
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.	From baseline to 36 months following up.

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Canceropôle Nord Ouest
• Investigators: Principal Investigator: Xavier MIRABEL, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: STEREOLIVER-1704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No