gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

Anaplastic Gliomas With 1p/19q Codeletion Clinical Trial

— POLCA  

Official title:

A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02444000
• Other study ID #: P130097
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 22, 2015
• Est. completion date: September 21, 2024

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: September 21, 2024
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Gliomas With 1p/19q Codeletion
• Glioma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	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	Groupe Hospitalier Pitié Salpetriere	Paris
France	HIA du Val de Grâce	Paris
France	Hopital Saint Louis	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-Étienne
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

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Association de Neuro-Oncologues d'Expression Francaise

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without neurocognitive deterioration	Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study registration to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.	9 years
Secondary	progression free survival		9 years
Secondary	overall survival		9 years