Informations générales (source: ClinicalTrials.gov)
A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery (POLO)
Interventional
Phase 3
Hospices Civils de Lyon (Voir sur ClinicalTrials)
décembre 2021
décembre 2030
05 avril 2025
Because of their prolonged survival, patients with 1p/19q-codeleted low-grade
oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We
make the hypothesis that withholding radiotherapy until tumor progression could reduce
the risk of neurocognitive deterioration without impairing overall survival.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Sarah DUMONT | 05/06/2024 09:53:08 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL FOCH | Nadia Younan, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - 35042 - Rennes - France | Elodie VAULEON, MD | Contact (sur clinicalTrials) | |||
| Centre Georges Francois Leclerc - 21000 - Dijon - France | François GHIRINGHELLI, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - 76038 - Rouen - France | Maxime FONTANILLES, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69008 - Lyon - France | Alice BONNEVILLE-LEVARD, MD | Contact (sur clinicalTrials) | |||
| CH Annecy Genevois site Annecy - 74374 - Pringy - France | Alexandre TESSIER, MD | Contact (sur clinicalTrials) | |||
| CHRU de Tours - 37044 - Tours - France | Ilyess ZEMMOURA, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU d'Amiens-Picardie Site Sud - 80054 - Amiens - France | Mathieu BOONE, MD | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux Hôpital Saint André - 33075 - Bordeaux - France | Charlotte BRONNIMANN, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14033 - Caen - France | Evelyne EMERY, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87042 - Limoges - France | Elise DELUCHE, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice Hôpital Pasteur - 06000 - Nice - France | Véronique BOURG, MD | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - 42055 - Saint-Étienne - France | Carole RAMIREZ, MD | Contact (sur clinicalTrials) | |||
| GH Pitié Salpêtrière - 75651 - Paris - France | Caroline DEHAIS, MD | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées PERCY - 92141 - Clamart - France | Damien RICARD, MD | Contact (sur clinicalTrials) | |||
| Hôpital Pasteur - Hôpitaux civils de Colmar - 68024 - Colmar - France | Guido AHLE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Roger Salengro CHU de Lille - 59037 - Lille - France | Apolline MONFILLIETTE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis, AP-HP - 75010 - Paris - France | Antoine CARPENTIER, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Timone - 13005 - Marseille - France | Olivier CHINOT, MD, PhD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - 69500 - Bron - France | François DUCRAY, MD, PhD | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de l'Ouest - 44805 - Saint-Herblain - France | Carole GOURMELON, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de l'Ouest - 49055 - Angers - France | Paule AUGEREAU, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan - 29200 - Brest - France | Benjamin AUBERGER, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Strasbourg Europe - 67200 - Strasbourg - France | Georges NOEL, MD, PhD | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse Oncopole - 31059 - Toulouse - France | Elizabeth MOYAL, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to
local diagnosis
- Histological confirmation of low-grade oligodendroglioma by central pathological
review according to WHO 2016 classification
- Age ≥ 18 years
- Patients with one or several prior surgical procedure for a low-grade
oligodendroglioma and who undergo a resurgery are eligible if they have not received
prior radiotheray or chemotherapy and if the last histological diagnosis is a
low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted
- Patients who undergo an initial follow-up after surgery or re-surgery are eligible
if there is no evidence of anaplastic transformation on MRI (no new contrast
enhancement, no obvious modification of the growth rate)
- Patients requiring an oncological treatment other than surgery because of one or
more of the following characteristics:
- Progressive disease defined as documented growth prior to inclusion
- Symptomatic disease defined as the presence of neurological or cognitive
symptoms or refractory seizures defined as having both persistent seizures
interfering with everyday life activities other than driving a car and three
lines of anti-epileptic drug regimen had not worked, including at least one
combination regimen.
- Age ≥ 40 and any surgical therapy
- Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than
gross total resection)
- Willing and able to complete neurocognitive examination and the QOL
- Karnofsky performance status ≥ 60
- Laboratory values obtained between 21 days before inclusion andrandomization,
respecting the following criteria:
- Absolute neutrophil count (ANC) ≥1500 /mm3
- Platelet count ≥100,000 / mm3
- Hemoglobin > 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT (AST) ≤ 3 x ULN
- Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for
women of childbearing potential only.
- Provide informed written consent
- Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to
local diagnosis
- Histological confirmation of low-grade oligodendroglioma by central pathological
review according to WHO 2016 classification
- Age ≥ 18 years
- Patients with one or several prior surgical procedure for a low-grade
oligodendroglioma and who undergo a resurgery are eligible if they have not received
prior radiotheray or chemotherapy and if the last histological diagnosis is a
low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted
- Patients who undergo an initial follow-up after surgery or re-surgery are eligible
if there is no evidence of anaplastic transformation on MRI (no new contrast
enhancement, no obvious modification of the growth rate)
- Patients requiring an oncological treatment other than surgery because of one or
more of the following characteristics:
- Progressive disease defined as documented growth prior to inclusion
- Symptomatic disease defined as the presence of neurological or cognitive
symptoms or refractory seizures defined as having both persistent seizures
interfering with everyday life activities other than driving a car and three
lines of anti-epileptic drug regimen had not worked, including at least one
combination regimen.
- Age ≥ 40 and any surgical therapy
- Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than
gross total resection)
- Willing and able to complete neurocognitive examination and the QOL
- Karnofsky performance status ≥ 60
- Laboratory values obtained between 21 days before inclusion andrandomization,
respecting the following criteria:
- Absolute neutrophil count (ANC) ≥1500 /mm3
- Platelet count ≥100,000 / mm3
- Hemoglobin > 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT (AST) ≤ 3 x ULN
- Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for
women of childbearing potential only.
- Provide informed written consent
- Pregnant and nursing women
- Men or women of childbearing potential who are unwilling to employ adequate
contraception for up to 6 months following the completion of PCV.
- Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
- Co-morbid systemic illnesses or other severe concurrent disease which would make the
patient inappropriate for entry into this study or interfere significantly with the
proper assessment of safety and toxicity of the prescribed regimens.
- Concomitant serious immunocompromised status (other than that related to concomitant
steroids).
- Uncontrolled intercurrent illness or psychiatric illness/social situations that
would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm (except specific inhibitors of IDH)
- Other active malignancy within 5 years of registration. Exceptions: Non-melanotic
skin cancer or carcinoma-in-situ of the cervix.
- Contra-indication to CCNU: hypersensitivity to CCNU, wheat allergy, association to
yellow fever vaccin
- Contra-indication to Procarbazine: severe renal failure, severe hepatic failure,
hypersensitivity to procarbazine, association to yellow fever vaccin
- Contra-indication to Vincristine: hypersensitivity to vincristine, neuromuscular
disorder (for example demyelinating Charcot-Mary Tooth neuropathy), severe renal
failure, severe hepatic failure.
- Not depending from the french system of health assurance