A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
POLO
2 other identifiers
interventional
280
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2021
Longer than P75 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedStudy Start
First participant enrolled
December 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
January 29, 2026
January 1, 2026
9 years
January 7, 2021
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 randomization 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.
During 9 years
Secondary Outcomes (2)
Progression free survival
During 9 years
Overall survival
During 9 years
Study Arms (2)
PCV alone
EXPERIMENTALAdministration of 6 cycles of PCV chemotherapy alone.
RT + PCV
ACTIVE COMPARATORRadiotherapy followed by administration of PCV chemotherapy.
Interventions
Radiotherapy will deliver 50.4 Gy in 28 fractions of 1.8 Gy using IMRT technique. Followed by 6 cycles of PCV chemotherapy 1 cycle of PCV 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
1. cycle of 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 6 cycles are given.
Eligibility Criteria
You may qualify if:
- 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:
- 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
- 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)
- +3 more criteria
You may not qualify if:
- Pregnant and nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception for up to 6 months following the completion of PCV.
- Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
- Co-morbid systemic illnesses or other severe concurrent disease which would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Concomitant serious immunocompromised status (other than that related to concomitant steroids).
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm (except specific inhibitors of IDH)
- Other active malignancy within 5 years of registration. Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
- Contra-indication to CCNU: hypersensitivity to CCNU, wheat allergy, association to yellow fever vaccin
- Contra-indication to Procarbazine: severe renal failure, severe hepatic failure, hypersensitivity to procarbazine, association to yellow fever vaccin
- Contra-indication to Vincristine: hypersensitivity to vincristine, neuromuscular disorder (for example demyelinating Charcot-Mary Tooth neuropathy), severe renal failure, severe hepatic failure.
- Not depending from the french system of health assurance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
CHU d'Amiens-Picardie Site Sud
Amiens, 80054, France
Institut de Cancerologie de l'Ouest
Angers, 49055, France
CHU de Bordeaux Hôpital Saint André
Bordeaux, 33075, France
Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan
Brest, 29200, France
Hospices Civils de Lyon
Bron, 69500, France
CHU de Caen
Caen, 14033, France
Hôpital d'Instruction des Armées PERCY
Clamart, 92141, France
Hôpital Pasteur - Hôpitaux civils de Colmar
Colmar, 68024, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Hôpital Roger Salengro CHU de Lille
Lille, 59037, France
CHU de Limoges
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69008, France
Hôpital Timone
Marseille, 13005, France
CHU de Nice Hôpital Pasteur
Nice, 06000, France
Hôpital Saint-Louis, AP-HP
Paris, 75010, France
GH Pitié Salpêtrière
Paris, 75651, France
CH Annecy Genevois site Annecy
Pringy, 74374, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
CHU Saint-Etienne
Saint-Etienne, 42055, France
Institut de Cancerologie de l'Ouest
Saint-Herblain, 44805, France
Centre de Lutte Contre le Cancer PAUL STRAUSS
Strasbourg, 67200, France
Hôpital Foch
Suresnes, 92150, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
CHRU de Tours
Tours, 37044, France
Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2021
First Posted
January 11, 2021
Study Start
December 7, 2021
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
January 29, 2026
Record last verified: 2026-01