Liver CancerSTEREOLIVERNCT03408665
Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer
A study testing SBRT in people with Liver Cancer and Liver Metastases, run by Centre Oscar Lambret at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastases
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 7 sitesFrance
- Study dates
- 13 Mar 2019to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Léonard de Vinci
Dechy
Centre Oscar Lambret
Lille, Nord, 59020
Institut Régional du Cancer de Montpellier
Montpellier
Institut de Cancérologie Paris Nord
Sarcelles, 95200
Centre Paul Strauss
Strasbourg
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: 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.
Read the 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
- Being tested
- SBRT
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
3 sessions at least, up to 6. Neither specifc device is imposed.
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
Measured: From baseline to 36 months following up.
Describe the different SBRT techniques used in the study for liver tumor.
Description of SBRT techniques used.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 36 months following up.
Quality of life according to QLQ-C30 questionnaire
QLQ-C30 will be filled at baseline, at the 3-months follow-up and at the 6-months follow-up.
Measured: From Baseline to the 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start13 Mar 2019
- Primary completion1 Dec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Canceropôle Nord Ouest
- Responsible party
- Sponsor
- Investigators
- Xavier MIRABEL, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408665
- Sponsor's protocol ID
- STEREOLIVER-1704
- Other IDs
- 2017-A02946-47
- Acronym
- STEREOLIVER
- Status last verified
- Mar 2026
- First submitted
- 4 Jan 2018
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
- ClinicalTrials.gov ID
- NCT03408665
- Acronym / sponsor ID
- STEREOLIVER / STEREOLIVER-1704
- Conditions
- Liver Cancer, Liver Metastases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Canceropôle Nord Ouest
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRTStereotaxic Body Radiation Therapy administred in 3 to 6 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT3 sessions at least, up to 6. Neither specifc device is imposed. | Radiation | SBRT |
Primary outcome
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
Time frame: From baseline to 36 months following up.
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
12 secondary outcomes
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.
Time frame: From baseline to 36 months following up.
Describe the different SBRT techniques used in the study for liver tumor.
Time frame: From baseline to 36 months following up.
Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 36 months following up.
Assess the immediate and delayed toxicity.
Time frame: From baseline to 36 months following up.
Estimate the quality-adjusted survival (Q-TWiST) for patients in each of the 4 considered clinical situations.
Time frame: From baseline to 36 months following up.
Estimate the proportion of patients for whom an hospitalization is required.
Time frame: From baseline to 36 months following up.
Estimate the impact of the different SBRT techniques on SBRT efficacy according to L-PFS.
Time frame: From baseline to 36 months following up.
Estimate the impact of the different SBRT techniques on SBRT efficacy according to PFS.
Time frame: From baseline to 36 months following up.
Estimate the impact of the different SBRT techniques on SBRT efficacy according to OS.
Time frame: From baseline to 36 months following up.
Quality of life according to QLQ-C30 questionnaire
Time frame: From Baseline to the 6-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier MIRABEL, MD principal investigator
Centre Oscar Lambret
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Liver Cancer and Liver Metastases, run by Centre Oscar Lambret at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From baseline to 36 months following up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.