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Aggressive chemo schedule put to the test in brain cancer trial

NCT ID NCT03663725

Disease control Sponsor: Centre Oscar Lambret 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether giving the chemotherapy drug temozolomide earlier and for a longer time can help adults with glioblastoma live longer. About 486 participants will receive either the standard treatment or an intensified version that starts chemo within two weeks of surgery and continues until the cancer progresses or side effects become too severe. The study aims to see if this more aggressive approach improves overall survival compared to the usual six-cycle regimen.

What this could mean

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

Active substance
temozolomide (chemotherapy)
What this could lead to
If successful, this could show that starting chemotherapy earlier and continuing it longer helps people with glioblastoma live longer.
What could go wrong
This is a phase 3 trial, but glioblastoma is very aggressive and hard to treat. The intensified regimen may cause more side effects without improving 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

About 486 people

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

Started

Mar 2019

Expected to finish

Jun 2027

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: * Patient ≥18 years old * Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study. * Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days) * Karnofsky performance status (KPS) ≥ 60%, or KPS \<60% only related to glioma-related motor paresis. * Adequate biological functions * Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms) * Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug. * Standard radiation therapy deemed feasible (60 Gy, 30 fractions) * Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy * Written informed consent Exclusion Criteria: * Secondary or recurrent glioblastoma (GBM) * Planned use of tumor-treating electric fields * Planned use of Carmustine implants * Prior malignancy in the last 5 years before inclusion or concomitant * Severe myelosuppression * Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC) * Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion). * Known current viral hepatitis, HIV infection or current active infectious disease * Inability to swallow oral medications or any mal-absorption condition * Pregnant or breastfeeding patients. * Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) * Person under guardianship or curatorship

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

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

Glioblastoma

Contacts and locations

Locations

  • APHP La Pitié Salpêtrière

    Paris, 75013, France

  • CH René Dubos

    Pontoise, 95300, France

  • CHRU Nancy

    Nancy, 54000, France

  • CHRU Tours

    Tours, 37044, France

  • CHU Grenoble Alpes

    Grenoble, 38043, France

  • CHU La Timone

    Marseille, 13385, France

  • CHU de Limoges

    Limoges, 87042, France

  • CHU de Nice - Hôpital de Cimiez

    Nice, 06000, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Hospitalier d'Amiens

    Amiens, 80054, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, 69673, France

  • Centre Paul Strauss

    Strasbourg, 67065, France

  • Hôpitaux Civils de Colmar

    Colmar, 68024, France

  • ICM Val d'Aurelle

    Montpellier, 34298, France

  • Institut Cancérologie Loire

    Saint-Priest-en-Jarez, 42270, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.