A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

Who is this study for? Patients with 1p/19q codeleted low-grade oligodendrogliomas requiring a treatment other than surgery
What treatments are being studied? PCV chemotherapy
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to local diagnosis

• Histological confirmation of low-grade oligodendroglioma by central pathological review according to WHO 2016 classification

• Age ≥ 18 years

• Patients with one or several prior surgical procedure for a low-grade oligodendroglioma and who undergo a resurgery are eligible if they have not received prior radiotheray or chemotherapy and if the last histological diagnosis is a low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted

• Patients who undergo an initial follow-up after surgery or re-surgery are eligible if there is no evidence of anaplastic transformation on MRI (no new contrast enhancement, no obvious modification of the growth rate)

• Patients requiring an oncological treatment other than surgery because of one or more of the following characteristics:

‣ Progressive disease defined as documented growth prior to inclusion

⁃ Symptomatic disease defined as the presence of neurological or cognitive symptoms or refractory seizures defined as having both persistent seizures interfering with everyday life activities other than driving a car and three lines of anti-epileptic drug regimen had not worked, including at least one combination regimen.

⁃ Age ≥ 40 and any surgical therapy

⁃ Age \< 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)

• Willing and able to complete neurocognitive examination and the QOL

• Karnofsky performance status ≥ 60

• Laboratory values obtained between 21 days before inclusion andrandomization, respecting the following criteria:

• 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

Locations
Other Locations
France
CHU d'Amiens-Picardie Site Sud
RECRUITING
Amiens
Institut de Cancerologie de l'Ouest
RECRUITING
Angers
CHU de Bordeaux Hôpital Saint André
RECRUITING
Bordeaux
Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan
RECRUITING
Brest
Hospices Civils de Lyon
RECRUITING
Bron
CHU de Caen
NOT_YET_RECRUITING
Caen
Hôpital d'Instruction des Armées PERCY
NOT_YET_RECRUITING
Clamart
Hôpital Pasteur - Hôpitaux civils de Colmar
NOT_YET_RECRUITING
Colmar
Centre Georges Francois Leclerc
NOT_YET_RECRUITING
Dijon
Hôpital Roger Salengro CHU de Lille
RECRUITING
Lille
CHU de Limoges
NOT_YET_RECRUITING
Limoges
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
Hôpital Timone
RECRUITING
Marseille
CHU de Nice Hôpital Pasteur
NOT_YET_RECRUITING
Nice
GH Pitié Salpêtrière
RECRUITING
Paris
Hôpital Saint-Louis, AP-HP
RECRUITING
Paris
CH Annecy Genevois site Annecy
NOT_YET_RECRUITING
Pringy
Centre Eugène Marquis
RECRUITING
Rennes
Centre Henri Becquerel
RECRUITING
Rouen
CHU Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
Institut de Cancerologie de l'Ouest
RECRUITING
Saint-herblain
Institut de Cancérologie Strasbourg Europe
RECRUITING
Strasbourg
Hôpital Foch
NOT_YET_RECRUITING
Suresnes
Institut Universitaire du Cancer Toulouse Oncopole
NOT_YET_RECRUITING
Toulouse
CHRU de Tours
NOT_YET_RECRUITING
Tours
Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
François DUCRAY, MD, PhD
francois.ducray@chu-lyon.fr
+33(0) 4 72 35 78 06
Backup
Cécile TROUBA
cecile.trouba@chu-lyon.fr
+33(0) 4 72 35 69 15
Time Frame
Start Date: 2021-12-07
Estimated Completion Date: 2030-12
Participants
Target number of participants: 280
Treatments
Experimental: PCV alone
Administration of 6 cycles of PCV chemotherapy alone.
Active_comparator: RT + PCV
Radiotherapy followed by administration of PCV chemotherapy.
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov