Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2015-09-22
2024-09-21
Brief Summary
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Detailed Description
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Number of centres participating: the 33 centers of the POLA network Recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental
Administration of 6 cycles of PCV chemotherapy 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
PCV chemotherapy alone
PCV cycles are 6 weeks long
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
control
radiotherapy followed by 6 cycles of PCV chemotherapy 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
Radiotherapy+PCV chemotherapy
Radiotherapy followed by 6 cycles of PCV
Interventions
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PCV chemotherapy alone
PCV cycles are 6 weeks long
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
Radiotherapy+PCV chemotherapy
Radiotherapy followed by 6 cycles of PCV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Association de Neuro-Oncologues d'Expression Francaise
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Caroline DEHAIS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU d'Amiens- CHU nord
Amiens, , France
CHU D'Anger
Angers, , France
CHU annecy genevois
Annecy, , France
CHU de Bordaux
Bordeaux, , France
Hopital de la Cavale Blanche
Brest, , France
CHU de Caen
Caen, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
CH Louis Pasteur
Colmar, , France
Hopital François Mitterand
Dijon, , France
CHU Sud Réunion
La Réunion, , France
Hopital Roger Salengro
Lille, , France
Chu Dupuytren
Limoges, , France
Centre Hospitalier de Bretagne Sud - Hôpital du Scorff
Lorient, , France
GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
Lyon, , France
Hôpital Pierre Wertheimer
Lyon, , France
CHU la Timone
Marseille, , France
Hopital CLAIRVAL
Marseille, , France
ICM, Institut régional du Cancer de Montpellier
Montpellier, , France
Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
Nantes, , France
Hopital PASTEUR
Nice, , France
HIA du Val de Grâce
Paris, , France
Hopital Saint Louis
Paris, , France
Groupe Hospitalier Pitié Salpetriere
Paris, , France
Centre Hospitalier Perpignan
Perpignan, , France
CHU de Poitiers
Poitiers, , France
CLCC Eugène Marquis
Rennes, , France
CHU de Rouen
Rouen, , France
Hôpital Nord, CHU de Saint-Etienne
Saint-Etienne, , France
Institut Pul STRAUSS
Strasbourg, , France
Hôpital Foch
Suresnes, , France
IUCT Oncopole - CLCC Institut Claudius Regaud
Toulouse, , France
CHU Bretonneau
Tours, , France
CLCC Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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P130917
Identifier Type: -
Identifier Source: org_study_id
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