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

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ClinicalTrials.gov Identifier: NCT03408665
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Liver Metastases Radiation: SBRT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 13, 2026
Estimated Study Completion Date : March 13, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.




Primary Outcome Measures :
  1. Estimate the SBRT efficiency in term of local progression-free survival (L-PFS) for patient who are to be treated with SBRT in one of the 3 following situations : inoperable hepatocellular carcinoma, liver metastasis and nodular cholangiocarcinoma. [ 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 Outcome Measures :
  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 3 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) for patient treated with SBRT in the 3 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) for patient treated with SBRT in the 3 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 3 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • If fiducial use, proper hematological functions (for fiducial placement) : PT > 50% ; platelets > 50,000/L ; aPTT < twice the normal value
  • 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
  • Meet the requirements for SBRT treatment:
  • Liver Metastasis (LM): oligometastatic disease
  • Hepatocellular Carcinoma (HCC): non eligible lesion to curative surgery
  • Cholangiocarcinoma (CC): nodular lesion
  • Able to receive a SBRT treatment according to the multidisciplinary consultation meeting
  • Tumor evaluated by CT-scan or MRI in the 28 days prior to inclusion
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408665


Contacts
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Contact: Julien THERY +33320295918 promotion@o-lambret.fr

Locations
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France
Centre Oscar Lambret Recruiting
Lille, Nord, France, 59020
Contact: Xavier MIRABEL, MD    +33320295911    x-mirabel@o-lambret.fr   
Principal Investigator: Xavier MIRABEL, MD         
Centre Léonard de Vinci Not yet recruiting
Dechy, France
Contact: Franck DARLOY, MD    +33327086062    fdarloy@clinique-psv.fr   
Principal Investigator: Franck DARLOY, MD         
Sub-Investigator: Damien CARLIER, MD         
Sub-Investigator: Louis GRAS, MD         
Sub-Investigator: Lise UCLA, MD         
Institut Régional du Cancer de Montpellier Not yet recruiting
Montpellier, France
Contact: Olivier RIOU, MD    +33467614737    olivier.riou@icm.unicancer.fr   
Principal Investigator: Olivier RIOU, MD         
Sub-Investigator: David AZRIA, PhD         
Centre Antoine Lacassagne Not yet recruiting
Nice, France
Contact: Karen BENEZERY, MD    +33492031269    karine.benezery@nice.unicancer.fr   
Principal Investigator: Karen BENEZERY, MD         
Sub-Investigator: Jérôme DOYEN, MD         
Sub-Investigator: Lorraine KREBS, MD         
Institut de Cancérologie Lucien Neuwirth Not yet recruiting
Saint-Priest-en-Jarez, France
Contact: Nicolas MAGNE, PhD    +33477917434    nicolas.magné@icloire.fr   
Principal Investigator: Nicolas MAGNE, PhD         
Sub-Investigator: Grégoire PIGNE, MD         
Sub-Investigator: Amel REHALIA-BLANCHARD, MD         
Centre Paul Strauss Not yet recruiting
Strasbourg, France
Contact: Georges NOEL, PhD    +33388252485    gnoel@strasbourg.unicancer.fr   
Principal Investigator: Georges NOEL, PhD         
Sub-Investigator: Jean-Baptiste CLAVIER, MD         
Sub-Investigator: Audrey KELLER, MD         
Sub-Investigator: Catherine SCHUMACHER, MD         
CHRU Tours - Hôpital Bretonneau Not yet recruiting
Tours, France
Contact: Gilles CALAIS, PhD    +33247478265    gilles.calais@chu-tours.fr   
Principal Investigator: Gilles CALAIS, PhD         
Sub-Investigator: Sophie CHAPET, MD         
Sub-Investigator: Guillaume JANORAY, MD         
Institut de Cancérologie de Lorraine Not yet recruiting
Vandœuvre-lès-Nancy, France
Contact: Didier PEIFFERT, PhD    +33383598431    d.peiffert@nancy.unicancer.fr   
Principal Investigator: Didier PEIFFERT, PhD         
Sub-Investigator: Anne-Sophie BAUMANN, MD         
Sub-Investigator: Sophie RENARD-OLDRINI, MD         
Sub-Investigator: Anne-Agathe SERRE, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Principal Investigator: Xavier MIRABEL, MD Centre Oscar Lambret

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03408665     History of Changes
Other Study ID Numbers: STEREOLIVER-1704
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases