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Brain tumor patients may skip radiation to save thinking skills

NCT ID NCT02444000

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether giving only PCV chemotherapy, instead of chemotherapy plus radiotherapy, could protect thinking abilities in people with a specific brain tumor (1p/19q codeleted anaplastic glioma). 280 newly diagnosed adults were randomly assigned to receive either PCV alone or radiotherapy followed by PCV. The main goal was to see if avoiding radiation helped preserve memory, language, and other cognitive functions without harming survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PCV chemotherapy (CCNU, vincristine, procarbazine)
What this could lead to
If successful, this could show that skipping radiotherapy reduces cognitive decline without shortening survival for people with this brain tumor.
What could go wrong
This is a completed trial, so results are known. The main risk is that avoiding radiotherapy might lead to earlier tumor progression or lower overall survival.

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

280 people

The number who actually took part.

Started

Sep 2015

Finished

Sep 2024

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 : Histological confirmation of anaplastic glioma by central pathological review * Tumor is co-deleted for 1p and 19q * Age ≥ 18 years of age * Newly diagnosed and ≤3 months from surgical diagnosis * Willing and able to complete neurocognitive examination and the QOL * Karnofsky performance status ≥ 60 * The following laboratory values obtained ≤ 21 days prior to registration: * 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 during this study and for up to 6 months following the completion of PCV. * Received any prior radiation therapy or chemotherapy for any CNS neoplasm.

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Conditions

The condition(s) this trial relates to.

grade III glioma IDH-mutant and 1p/19q-codeleted oligodendroglioma

As listed by the trial registrant

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

Anaplastic gliomas with 1p/19q codeletion

Contacts and locations

Locations

  • CH Louis Pasteur

    Colmar, 68000, France

  • CHU Bretonneau

    Tours, 37000, France

  • CHU D'Anger

    Angers, 49000, France

  • CHU Sud Réunion

    La Réunion, 97000, France

  • CHU annecy genevois

    Annecy, 74000, France

  • CHU d'Amiens- CHU nord

    Amiens, 80000, France

  • CHU de Bordaux

    Bordeaux, 33000, France

  • CHU de Caen

    Caen, 30000, France

  • CHU de Poitiers

    Poitiers, 86000, France

  • CHU de Rouen

    Rouen, 76000, France

  • CHU la Timone

    Marseille, 13000, France

  • CLCC Eugène Marquis

    Rennes, 44000, France

  • CLCC Institut Gustave Roussy

    Villejuif, 94800, France

  • Centre Hospitalier Perpignan

    Perpignan, 49000, France

  • Centre Hospitalier de Bretagne Sud - Hôpital du Scorff

    Lorient, 56000, France

  • Chu Dupuytren

    Limoges, 87000, France

  • GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

    Lyon, 69000, France

  • Groupe Hospitalier Pitié Salpetriere

    Paris, 75013, France

  • HIA du Val de Grâce

    Paris, 75005, France

  • Hopital CLAIRVAL

    Marseille, 13000, France

  • Hopital François Mitterand

    Dijon, 21000, France

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • Hopital PASTEUR

    Nice, 06000, France

  • Hopital Roger Salengro

    Lille, 59000, France

  • Hopital Saint Louis

    Paris, 75010, France

  • Hopital de la Cavale Blanche

    Brest, 29000, France

  • Hôpital Foch

    Suresnes, 92000, France

  • Hôpital Nord, CHU de Saint-Etienne

    Saint-Etienne, 42000, France

  • Hôpital Pierre Wertheimer

    Lyon, 69000, France

  • ICM, Institut régional du Cancer de Montpellier

    Montpellier, 34000, France

  • IUCT Oncopole - CLCC Institut Claudius Regaud

    Toulouse, 31000, France

  • Institut Pul STRAUSS

    Strasbourg, 67000, France

  • Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau

    Nantes, 44000, France