Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
Not provided
Not provided
Not provided
Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi.
The doses delivered to these structures are crucial and radiotherapy of cavernous sinus meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy, cognitive impairment…). In 2012, Gondi reported that a dose given to 40% of the bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in list-learning delayed recall after FSRT for benign or low-grade adult brain tumors.
There is no published or recruiting prospective study evaluating the impact of proton-therapy or conventional irradiation on neurocognitive function for meningioma patients. Notably, long-term cognitive or ocular impact of these modern irradiation schemes remains poorly known. Yet, these patients had a long life-expectancy, and are at risk of developing long-term sequelae. Thus, according to its ballistic advantage, an improvement of patient functional outcomes and a reduction of neurocognitive long-term toxicity are expected if tissue sparing proton-therapy is used.
In this context, a randomized prospective study, evaluating long-term toxicity of these two irradiation modalities (Proton Therapy (PRT) and photon radiotherapy (XRT)) seems crucial to further assess proton-therapy indication for these patients.
Although literature reports excellent outcomes for intracranial meningioma patients treated by proton-therapy, none of the eight retrospective studies found in the literature used an accurate and full evaluation of long-term toxicity
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proton-therapy | Experimental | Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions) |
|
| photon radiotherapy | Active Comparator | Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton-therapy | Radiation | Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| functional deterioration evaluated by individual neurocognitive test scores | Neurocognitive deterioration defined as the occurrence of cognitive impairment (a total of 5 impaired z-scores (17 z-scores for 6 different tests) | 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeanne RIVERAIN, MD | Contact | +33 2 31 45 50 50 | j.riverain@baclesse.unicancer.fr | |
| Jean-Michel GRELLARD | Contact | +33 2 31 45 50 50 | jm.grellard@baclesse.unicancer.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Francois Baclesse | Recruiting | Caen | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39736544 | Derived | Lesueur P, Clarisse B, Lequesne J, Licaj I, Feuvret L, Stefan D, Ricard D, Noel G, Balosso J, Lange M, Capel A, Durand-Zaleski I, Castera M, Legrand B, Goliot N, Hedou C, Grellard JM, Valable S. Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01). BMC Cancer. 2024 Dec 30;24(1):1594. doi: 10.1186/s12885-024-13353-9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multicenter prospective comparative phase 3 randomized 1:1 trial
Not provided
Not provided
Not provided
Not provided
| Photon radiotherapy | Radiation | Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions) |
|
| Hopital d'Instruction des Armées PERCY | Not yet recruiting | Clamart | France |
|
| CHU Grenoble-Alpes | Not yet recruiting | Grenoble | France |
|
| Centre Guillaume le Conquerant | Not yet recruiting | Le Havre | France |
|
| Centre Léon Bérard | Not yet recruiting | Lyon | France |
|
| Hospices civils de Lyon | Not yet recruiting | Lyon | France |
|
| Centre Antoine Lacassagne | Not yet recruiting | Nice | France |
|
| Hôpital Pitié Salpétrière | Not yet recruiting | Paris | France |
|
| Institut Curie | Recruiting | Paris | France |
|
| Institut Curie | Not yet recruiting | Saint-Cloud | France |
|
| Centre Paul Strauss | Not yet recruiting | Strasbourg | France |
|
| IUCT | Recruiting | Toulouse | France |
|
| Gustave Rousy | Not yet recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
Not provided
Not provided