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NCT Number: NCT03408665

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret, Lille, Nord, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBRT

Radiation

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

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

    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.

Secondary outcomes

  1. 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.

    Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.

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

    Time frame: From baseline to 36 months following up.

    Description of SBRT techniques used.

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

    Time frame: From baseline to 36 months following up.

    Description of reasons leading to SBRT scheme modification or interruption.

  4. 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.

    Overall survivall thanks to Kaplan-meier method, from registration date to date of death.

  5. 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.

    Progression-free survival (PFS) thanks to Kaplan-Meier method from registration date to date of progressive disease.

  6. Assess the immediate and delayed toxicity.

    Time frame: From baseline to 36 months following up.

    Description of toxicity associated to SBRT or the fiducial use thanks to NCI-CTCAE v4.0.

  7. 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.

    Q-TWIST consists in 3 clinical states: time in toxicity before progressive disease, time in progressive disease, time without toxicity nor progressive disease.

  8. Estimate the proportion of patients for whom an hospitalization is required.

    Time frame: From baseline to 36 months following up.

    during the treatment and until 3 months after and the cumulative duration of the hospitalization over those 3 months.

  9. Estimate the impact of the different SBRT techniques on SBRT efficacy according to L-PFS.

    Time frame: From baseline to 36 months following up.

    Estimation of impact of SBRT technique used on SBRT efficacy according to L-PFS.

  10. Estimate the impact of the different SBRT techniques on SBRT efficacy according to PFS.

    Time frame: From baseline to 36 months following up.

    Estimation of impact of SBRT technique used on SBRT efficacy according to PFS.

  11. Estimate the impact of the different SBRT techniques on SBRT efficacy according to OS.

    Time frame: From baseline to 36 months following up.

    Estimation of impact of SBRT technique used on SBRT efficacy according to OS.

  12. Quality of life according to QLQ-C30 questionnaire

    Time frame: From Baseline to the 6-months follow-up

    QLQ-C30 will be filled at baseline, at the 3-months follow-up and at the 6-months follow-up.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Canceropôle Nord Ouest

Registry information

Official study title

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

Acronym: STEREOLIVER

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 24, 2018
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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