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

  • End date
    Dec 6, 2030
  • participants needed
  • sponsor
    Hospices Civils de Lyon
Updated on 6 July 2022
platelet count
karnofsky performance status
neutrophil count
tumor progression


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note