Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer (STEREOLIVER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03408665|
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : August 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Liver Metastases||Radiation: SBRT||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.
3 sessions at least, up to 6. Neither specifc device is imposed.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Julien THERYemail@example.com|
|Centre Oscar Lambret||Recruiting|
|Lille, Nord, France, 59020|
|Contact: Xavier MIRABEL, MD +33320295911 firstname.lastname@example.org|
|Principal Investigator: Xavier MIRABEL, MD|
|Sub-Investigator: Antoine CARLIER, MD|
|Sub-Investigator: Florence LE TINIER, MD|
|Sub-Investigator: Xavier LIEM, MD|
|Sub-Investigator: David PASQUIER, MD|
|Centre Léonard de Vinci||Recruiting|
|Contact: Franck DARLOY, MD +33327086062 email@example.com|
|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||Recruiting|
|Contact: Olivier RIOU, MD +33467614737 firstname.lastname@example.org|
|Principal Investigator: Olivier RIOU, MD|
|Sub-Investigator: David AZRIA, PhD|
|Sub-Investigator: Sylvain DEMONTOY, MD|
|Sub-Investigator: Alexis LENGLET, MD|
|Sub-Investigator: Carmen LLACER, MD|
|Centre Antoine Lacassagne||Withdrawn|
|Nice, France, 06189|
|Institut de Cancérologie Lucien Neuwirth||Not yet recruiting|
|Contact: Nicolas MAGNE, PhD +33477917434 nicolas.magné@icloire.fr|
|Principal Investigator: Nicolas MAGNE, PhD|
|Sub-Investigator: Amel REHALIA-BLANCHARD, MD|
|Institut de Cancérologie Paris Nord||Recruiting|
|Sarcelles, France, 95200|
|Contact: Anne LARROUY, MD email@example.com|
|Principal Investigator: Anne LARROUY, MD|
|Sub-Investigator: Julie GIROUX, MD|
|Sub-Investigator: Guiilaume SERGENT, MD|
|Centre Paul Strauss||Recruiting|
|Contact: Georges NOEL, PhD +33388252485 firstname.lastname@example.org|
|Principal Investigator: Georges NOEL, PhD|
|Sub-Investigator: Jean-Baptiste CLAVIER, MD|
|Sub-Investigator: Audrey KELLER, MD|
|Sub-Investigator: Catherine SCHUMACHER, MD|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31059|
|Contact: Anouchka MODESTO, MD +33 05.31.15.54.44 email@example.com|
|Sub-Investigator: Lekhal Amina BOUAMAMA, MD|
|CHRU Tours - Hôpital Bretonneau||Not yet recruiting|
|Contact: Gilles CALAIS, PhD +33247478265 firstname.lastname@example.org|
|Principal Investigator: Gilles CALAIS, PhD|
|Sub-Investigator: Sophie CHAPET, MD|
|Sub-Investigator: Guillaume JANORAY, MD|
|Sub-Investigator: Ossama DIDAS, MD|
|Sub-Investigator: Aurélien ROBERT, MD|
|Sub-Investigator: Alice THERON, MD|
|Institut de Cancérologie de Lorraine||Recruiting|
|Vandœuvre-lès-Nancy, France, 54519|
|Contact: Didier PEIFFERT, PhD +33383598431 email@example.com|
|Principal Investigator: Didier PEIFFERT, PhD|
|Sub-Investigator: Anne-Sophie BAUMANN, MD|
|Sub-Investigator: Maria JOLNEROVSKI, MD|
|Sub-Investigator: Paul JUNG, MD|
|Sub-Investigator: Myriam KHADIGE, MD|
|Sub-Investigator: Jean François PY, MD|
|Sub-Investigator: Anaïs STEFANI, MD|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94800|
|Contact: Jérôme DURAND-LABRUNIE, MD 01.42.11.42.11 firstname.lastname@example.org|
|Principal Investigator: Jérôme DURAND-LABRUNIE, MD|
|Sub-Investigator: Valérie BOIGE, MD|
|Sub-Investigator: Pascal BURTIN, MD|
|Sub-Investigator: Michel DUCREUX, PhD|
|Sub-Investigator: Alina FUEREA, MD|
|Sub-Investigator: Antoine HOLLEBECQUE, MD|
|Sub-Investigator: David MALKA, MD|
|Sub-Investigator: Margarida MATIAS, MD|
|Sub-Investigator: Eric DEUTSCH, PhD|
|Sub-Investigator: Claire PETIT, MD|
|Sub-Investigator: Caroline PRIEUX-KLOTZ, MD|
|Principal Investigator:||Xavier MIRABEL, MD||Centre Oscar Lambret|