Clinical trial NCT02444000: gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas
Official title: A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anaplastic Gliomas With 1p/19q Codeletion
Keywords: chemotherapy
PCV
radiotherapy
post operative treatment
anaplastic gliomas
1p/19q codeletion
cognition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association de Neuro-Oncologues d'Expression Francaise
First posted: 2015-05-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Multicentric, Randomized phase III study (1:1), Population: newly diagnosed 1p/19-codeleted anaplastic gliomas, Primary objective: To determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with PCV alone can increase overall survival without neurocognitive deterioration Control group: radiotherapy followed by 6 cycles of PCV chemotherapy. Experimental group: 6 cycles of PCV chemotherapy (radiotherapy being deferred at the time of progression).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival without neurocognitive deterioration
timeFrame: 9 years
Secondary outcomes:
measure: progression free survival
timeFrame: 9 years
measure: overall survival
timeFrame: 9 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens- CHU nord
city: Angers
country: France
facility: CHU D'Anger
city: Annecy
country: France
facility: CHU annecy genevois
city: Bordeaux
country: France
facility: CHU de Bordaux
city: Brest
country: France
facility: Hopital de la Cavale Blanche
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Colmar
country: France
facility: CH Louis Pasteur
city: Dijon
country: France
facility: Hopital François Mitterand
city: La Réunion
country: France
facility: CHU Sud Réunion
city: Lille
country: France
facility: Hopital Roger Salengro
city: Limoges
country: France
facility: Chu Dupuytren
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud - Hôpital du Scorff
city: Lyon
country: France
facility: GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
city: Lyon
country: France
facility: Hôpital Pierre Wertheimer
city: Marseille
country: France
facility: CHU la Timone
city: Marseille
country: France
facility: Hopital CLAIRVAL
city: Montpellier
country: France
facility: ICM, Institut régional du Cancer de Montpellier
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
city: Nice
country: France
facility: Hopital PASTEUR
city: Paris
country: France
facility: HIA du Val de Grâce
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpetriere
city: Perpignan
country: France
facility: Centre Hospitalier Perpignan
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CLCC Eugène Marquis
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Étienne
country: France
facility: Hôpital Nord, CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Institut Pul STRAUSS
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: IUCT Oncopole - CLCC Institut Claudius Regaud
city: Tours
country: France
facility: CHU Bretonneau
city: Villejuif
country: France
facility: CLCC Institut Gustave Roussy
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Caroline DEHAIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: