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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002706-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "perPDT" | Experimental | Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "perPDT" | Device | The protocol requires the realization of specific procedures in addition to the usual care. The per-operative photodynamic therapy ("perPDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0 | In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period. Target: At least 6/10 patients who benefited of complete "PerPDT" and without unacceptable and unexpected toxicities | From the intake of Gliolan (5-Ala) until 1 month post "perPDT" |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Determined according to international RANO criteria | From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months |
| Overall Survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze of Peripheral Blood Mononuclear Cells | Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":
Contraindications to 5-ALA
Contraindications to surgery
Contraindications to magnetic resonance imaging (MRI)
Treatment with an experimental drug within 30 Days prior to the start of the study
Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
Pregnant or nursing women
Refusal to participate or sign the consent of the study
Soy allergy
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Reyns, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHRU | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33743128 | Result | Vermandel M, Dupont C, Lecomte F, Leroy HA, Tuleasca C, Mordon S, Hadjipanayis CG, Reyns N. Standardized intraoperative 5-ALA photodynamic therapy for newly diagnosed glioblastoma patients: a preliminary analysis of the INDYGO clinical trial. J Neurooncol. 2021 May;152(3):501-514. doi: 10.1007/s11060-021-03718-6. Epub 2021 Mar 20. | |
| 38753093 |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| GLIOLAN | Drug | patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery |
|
Determined according to international RANO criteria
| From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months |
| Response to treatment | Evaluated by MRI every 3 months | From the date of perPDT until relapse/death, assessed up to 24 months |
| Incidence of "per PDT" treatment-emergent Adverse Events | Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board. | From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months |
| Quality of Life Questionnaire -C30 ( QLQ-C30) | The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. | Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months |
| Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20) | Measuring the health-related quality of life in patients with brain cancer | Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months |
| Peciu-Florianu I, Vannod-Michel Q, Vauleon E, Bonneterre ME, Reyns N. Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240). J Neurooncol. 2024 Jul;168(3):495-505. doi: 10.1007/s11060-024-04693-4. Epub 2024 May 16. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |