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Recruiting Phase 3

A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

NCT04702581 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2021-12-07
Last updated
2026-01-29

Condition(s) studied

OligodendrogliomaLow-grade Oligodendroglioma1p19q Codeletion

Investigational drug(s) / intervention(s)

PCV chemotherapyRadiotherapy and PCV chemotherapy

PCV chemotherapy: 1. cycle of PCV chemotherapy is given as: * Day 1: CCNU 110 mg/m2 orally; * Days 8 and 29: Vincristine 1.4 mg/m2 IV; * Days 8 to 21: Procarbazine 60 mg/m2 orally 6 cycles are given.

Radiotherapy and PCV chemotherapy: Radiotherapy will deliver 50.4 Gy in 28 fractions of 1.8 Gy using IMRT technique. Followed by 6 cycles of PCV chemotherapy 1 cycle of PCV is given as: * Day 1: CCNU 110 mg/m2 orally; * Days 8 and 29: Vincristine 1.4 mg/m2 IV; * Days 8 to 21: Procarbazine 60 mg/m2 orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Survival without neurocognitive deterioration — During 9 years
    Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study randomization to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.

Trial sites (26)

FacilityCityRegionStatus
CHU d'Amiens-Picardie Site Sud Amiens France Recruiting
Institut de Cancerologie de l'Ouest Angers France Recruiting
CHU de Bordeaux Hôpital Saint André Bordeaux France Recruiting
Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan Brest France Recruiting
Hospices Civils de Lyon Bron France Recruiting
CHU de Caen Caen France Not Yet Recruiting
Hôpital d'Instruction des Armées PERCY Clamart France Not Yet Recruiting
Hôpital Pasteur - Hôpitaux civils de Colmar Colmar France Not Yet Recruiting
Centre Georges Francois Leclerc Dijon France Not Yet Recruiting
Hôpital Roger Salengro CHU de Lille Lille France Recruiting
CHU de Limoges Limoges France Not Yet Recruiting
Centre Léon Bérard Lyon France Not Yet Recruiting
Hôpital Timone Marseille France Recruiting
CHU de Nice Hôpital Pasteur Nice France Not Yet Recruiting
Hôpital Saint-Louis, AP-HP Paris France Recruiting
GH Pitié Salpêtrière Paris France Recruiting
CH Annecy Genevois site Annecy Pringy France Not Yet Recruiting
Centre Eugène Marquis Rennes France Recruiting
Centre Henri Becquerel Rouen France Recruiting
CHU Saint-Etienne Saint-Etienne France Not Yet Recruiting
Institut de Cancerologie de l'Ouest Saint-Herblain France Recruiting
Centre de Lutte Contre le Cancer PAUL STRAUSS Strasbourg France Recruiting
Hôpital Foch Suresnes France Not Yet Recruiting
Institut Universitaire du Cancer Toulouse Oncopole Toulouse France Not Yet Recruiting
CHRU de Tours Tours France Not Yet Recruiting
Gustave Roussy Villejuif France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04702581 on ClinicalTrials.gov ↗ ← All trials in France