A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery (POLO)

  • STATUS
    Recruiting
  • End date
    Dec 6, 2030
  • participants needed
    280
  • sponsor
    Hospices Civils de Lyon
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Updated on 6 July 2022
See if I qualify
platelet count
vincristine
karnofsky performance status
IDH2
neutrophil count
oligodendroglioma
tumor progression
antiepileptic

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.

Details
Condition Oligodendroglioma, Low-grade Oligodendroglioma, 1p19q Codeletion
Treatment PCV chemotherapy, Radiotherapy and PCV chemotherapy
Clinical Study IdentifierNCT04702581
SponsorHospices Civils de Lyon
Last Modified on6 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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
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 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
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
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