A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma (STERIMGLI)
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|ClinicalTrials.gov Identifier: NCT02866747|
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : March 28, 2022
This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part.
The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.
Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:
- Arm A (control arm): Radiation therapy alone
- Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Radiation: Hypofractionated stereotactic radiation therapy Drug: Durvalumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)|
|Actual Study Start Date :||January 17, 2017|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Arm A: radiation therapy alone
Hypofractionated stereotactic radiation therapy (hFSRT) 24 Gray (Gy), 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 of the radiotherapy (RT), Day 3 RT and Day 5 RT.
Radiation: Hypofractionated stereotactic radiation therapy
Experimental: Arm B: combined treatment
hFSRT 24 Gy, 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 RT, Day 3 RT and Day 5 RT, combined with Durvalumab infusion: first administration of Durvalumab* on Day 5 RT (i.e. the same day after the last fraction of radiation, corresponding to the Day 1 for Durvalumab treatment) and then administration of Durvalumab 1500 milligrams (mg) every four weeks.
* Dosing 750 mg or 1500 mg, according to the recommended combination schema determined in phase I.
Radiation: Hypofractionated stereotactic radiation therapy
- Phase I: Dose Limiting Toxicities (DLT) incidence [ Time Frame: 8 months ]For each patient of the phase I part, DLT incidence will be evaluated until one month after the last radiotherapy fraction.
- Phase II: overall survival [ Time Frame: 36 months post randomization ]
- Phase I and II: Intracranial progression-free interval [ Time Frame: 27 months ]Intracranial progression-free interval is defined by the time from inclusion (for phase I) or randomization (for phase II) to local or distant (outside the re-irradiated volume) progression. Patients without progression at last follow-up news are censored at this date.
- Phase I: Safety and tolerability according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03 [ Time Frame: 19 months ]
- Phase I and II: Quality of life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ C30). [ Time Frame: 27 months ]
- Phase I and II : Quality of life using the using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Brain Neoplasm (QLQ-BN20). [ Time Frame: 27 months ]
- Phase I and II: Neurologic and neurocognitive functions using Neurologic Assessment in Neuro-Oncology (NANO) scale. [ Time Frame: 27 months ]
- Phase I and II: Neurologic and neurocognitive functions using Neurologic Assessment in Montreal Cognitive Assessment (MoCA) tests. [ Time Frame: 27 months ]
- Phase II: Time to Quality of Life (QoL) deterioration. [ Time Frame: 27 months ]Time to QoL deterioration is defined as the time interval between randomization and first decrease in QoL score greater or equal to 5 points. Patients without such a QoL decrease will be censored at last follow-up news or at initiation of a new therapeutic strategy.
- Phase II: time to neurocognitive deterioration [ Time Frame: 27 months ]Time to neurocognitive deterioration is defined as the time interval between randomization and first of 3 points difference in MoCA as minimal clinically important difference. Patients without such a neurocognitive decrease will be censored at last follow-up news or at initiation of a new therapeutic strategy.
- Phase II: Immune-related intracranial progression-free interval [ Time Frame: 27 months ]Immune-related intracranial progression-free interval is defined by the time from randomization to local or distant (outside the re-irradiated volume) progression (based on immunotherapy Response Assessment for Neuro-Oncology iRANO). Patients without progression at last follow-up news are censored at this date.
- Phase II: Acute and late toxicities according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03 [ Time Frame: 27 months ]
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): NCT02866747
|Contact: Elizabeth COHEN-JONATHAN MOYAL, MD, PhD||+33 5 31 15 99 firstname.lastname@example.org|
|Contact: Muriel MOUNIER, PharmD||+33 5 31 15 58 email@example.com|
|Institut de Cancerologie de L'Ouest||Recruiting|
|Angers, France, 49055|
|Contact: Maud AUMONT, MD 02 40 67 99 00 Maud.firstname.lastname@example.org|
|Hopital Avicenne||Not yet recruiting|
|Bobigny, France, 93 000|
|Contact: Antoine CARPENTIER, MD +33 1 48 95 54 01 email@example.com|
|Principal Investigator: Antoine CARPENTIER, MD|
|Centre Francois Baclesse||Recruiting|
|Caen, France, 14 000|
|Contact: Paul LESUEUR, MD 02 31 45 50 20 firstname.lastname@example.org|
|Centre Georges Francois Leclerc||Recruiting|
|Dijon, France, 21 000|
|Contact: Gilles TRUC, MD +33 3 80 73 75 18 email@example.com|
|Principal Investigator: Gilles TRUC, MD|
|Institut Regional Du Cancer de Montpellier||Recruiting|
|Montpellier, France, 34 298|
|Contact: Marie CHARISSOUX, MD +33 4 67 61 37 16 firstname.lastname@example.org|
|Principal Investigator: Marie CHARISSOUX, MD|
|Hopital Pitie Salpetriere||Recruiting|
|Paris, France, 75013|
|Contact: Loïc FEUVRET, MD +33 1 42 17 81 60 email@example.com|
|Principal Investigator: Loïc FEUVRET, MD|
|Institut Curie||Not yet recruiting|
|Saint Cloud, France, 92 210|
|Contact: Patricia MOISSON, MD 01 41 11 15 15 firstname.lastname@example.org|
|Principal Investigator: Patricia MOISSON, MD|
|Centre Paul Strauss||Recruiting|
|Strasbourg, France, 67000|
|Contact: Georges NOEL, MD +33 3 88 25 24 78 email@example.com|
|Principal Investigator: Georges NOEL, MD|
|Institut Claudius Regaud||Recruiting|
|Contact: Elizabeth COHEN-JONATHAN MOYAL, MD, PhD + 33 5 31 15 99 07 firstname.lastname@example.org|
|Principal Investigator: Elizabeth MOYAL-JONATHAN COHEN, MD,PhD|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94 800|
|Contact: Frédéric D'HERMAIN, MD +33 1 42 11 62 20 Frederic.email@example.com|
|Principal Investigator: Frédéric D'HERMAIN, MD|