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Could waiting on radiation save your brain? new trial investigates

NCT ID NCT04702581

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people with a specific type of slow-growing brain tumor (oligodendroglioma) that needs treatment beyond surgery. The goal is to see if waiting to start radiation until the tumor grows back can help protect memory and thinking skills, without shortening how long people live. About 280 adults will be randomly assigned to get radiation right away or only when the tumor progresses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

oligodendroglial tumor oligodendroglioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

1P19Q codeletion Low-grade oligodendroglioma Oligodendroglioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Annecy Genevois site Annecy

    NOT_YET_RECRUITING

    Pringy, 74374, France

  • CHRU de Tours

    NOT_YET_RECRUITING

    Tours, 37044, France

  • CHU Saint-Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42055, France

  • CHU d'Amiens-Picardie Site Sud

    RECRUITING

    Amiens, 80054, France

  • CHU de Bordeaux Hôpital Saint André

    RECRUITING

    Bordeaux, 33075, France

  • CHU de Caen

    NOT_YET_RECRUITING

    Caen, 14033, France

  • CHU de Limoges

    NOT_YET_RECRUITING

    Limoges, 87042, France

  • CHU de Nice Hôpital Pasteur

    NOT_YET_RECRUITING

    Nice, 06000, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre Georges Francois Leclerc

    NOT_YET_RECRUITING

    Dijon, 21000, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76038, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, 69008, France

  • Centre de Lutte Contre le Cancer PAUL STRAUSS

    RECRUITING

    Strasbourg, 67200, France

  • GH Pitié Salpêtrière

    RECRUITING

    Paris, 75651, France

  • Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Hospices Civils de Lyon

    RECRUITING

    Bron, 69500, France

  • Hôpital Foch

    NOT_YET_RECRUITING

    Suresnes, 92150, France

  • Hôpital Pasteur - Hôpitaux civils de Colmar

    NOT_YET_RECRUITING

    Colmar, 68024, France

  • Hôpital Roger Salengro CHU de Lille

    RECRUITING

    Lille, 59037, France

  • Hôpital Saint-Louis, AP-HP

    RECRUITING

    Paris, 75010, France

  • Hôpital Timone

    RECRUITING

    Marseille, 13005, France

  • Hôpital d'Instruction des Armées PERCY

    NOT_YET_RECRUITING

    Clamart, 92141, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Institut de Cancerologie de l'Ouest

    RECRUITING

    Angers, 49055, France

  • Institut de Cancerologie de l'Ouest

    RECRUITING

    Saint-Herblain, 44805, France

  • Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan

    RECRUITING

    Brest, 29200, France

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