CompletedPhase 3

gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

France280 participantsStarted 2015-09-22

Plain-language summary

Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival without neurocognitive deterioration

Timeframe: 9 years

Trial details

NCT IDNCT02444000

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-11

View on ClinicalTrials.gov More Anaplastic Gliomas With 1p/19q Codeletion trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.