OligodendrogliomaPhase 3POLONCT04702581
A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
A Phase 3 study testing PCV chemotherapy and Radiotherapy and PCV chemotherapy in people with Oligodendroglioma and Low-grade Oligodendroglioma, run by Hospices Civils de Lyon at 26 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligodendroglioma, Low-grade Oligodendroglioma, 1p19q Codeletion
- What is being tested?
- PCV chemotherapy and Radiotherapy and PCV chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 26 sitesFrance
- Study dates
- 7 Dec 2021to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
France26 sites, 26 recruiting
- Recruiting
CHU d'Amiens-Picardie Site Sud
Amiens, 80054
Mathieu BOONE, MD, 03 22 45 54 99, Boone.mathieu@chu-amiens.fr
- Recruiting
Institut de Cancerologie de l'Ouest
Angers, 49055
Paule AUGEREAU, MD, 02 41 35 27 00, paule.augereau@ico.unicancer.fr
- Recruiting
CHU de Bordeaux Hôpital Saint André
Bordeaux, 33075
Charlotte BRONNIMANN, MD, 05 56 79 58 08, charlotte.bronnimann@chu-bordeaux.fr
- Recruiting
Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan
Brest, 29200
Benjamin AUBERGER, MD, 02 98 22 33 95, benjamin.auberger@chu-brest.fr
- Recruiting
Hospices Civils de Lyon
Bron, 69500
François DUCRAY, MD, PhD, 4 72 35 78 06 ext. +33, francois.ducray@chu-lyon.fr
Cécile TROUBA, 4 72 35 69 15 ext. +33, cecile.trouba@chu-lyon.fr
- Not yet recruiting
CHU de Caen
Caen, 14033
Evelyne EMERY, MD, 02 31 06 46 12, emery-e@chu-caen.fr
- Not yet recruiting
Hôpital d'Instruction des Armées PERCY
Clamart, 92141
Damien RICARD, MD, 01 41 46 68 85, damien.ricard@m4x.org
- Not yet recruiting
Hôpital Pasteur - Hôpitaux civils de Colmar
Colmar, 68024
Guido AHLE, MD, 03 89 12 41 54, guido.ahle@ch-colmar.fr
- Not yet recruiting
Centre Georges Francois Leclerc
Dijon, 21000
François GHIRINGHELLI, MD, 03 80 73 75 06, FGhiringhelli@cgfl.fr
- Recruiting
Hôpital Roger Salengro CHU de Lille
Lille, 59037
Apolline MONFILLIETTE, MD, 03 20 44 66 21, apolline.djelad@chru-lille.fr
- Not yet recruiting
CHU de Limoges
Limoges, 87042
Elise DELUCHE, MD, 05 55 05 61 00, elise.deluche@chu-limoges.fr
- Not yet recruiting
Centre Léon Bérard
Lyon, 69008
Alice BONNEVILLE-LEVARD, MD, 04 69 16 66 02, alice.bonneville-levard@lyon.unicancer.fr
- Recruiting
Hôpital Timone
Marseille, 13005
Olivier CHINOT, MD, PhD, 04 91 38 55 00, olivier.chinot@ap-hm.fr
- Not yet recruiting
CHU de Nice Hôpital Pasteur
Nice, 06000
Véronique BOURG, MD, 04 92 03 82 80, bourg.v@chu-nice.fr
- Recruiting
Hôpital Saint-Louis, AP-HP
Paris, 75010
Antoine CARPENTIER, MD, PhD, 01 71 20 74 66, antoine.carpentier@aphp.fr
- Recruiting
GH Pitié Salpêtrière
Paris, 75651
Caroline DEHAIS, MD, 01 42 16 04 35, caroline.dehais@aphp.fr
- Not yet recruiting
CH Annecy Genevois site Annecy
Pringy, 74374
Alexandre TESSIER, MD, 04 50 63 65 93, atessier@ch-annecygenevois.fr
- Recruiting
Centre Eugène Marquis
Rennes, 35042
Elodie VAULEON, MD, 02 99 25 31 82, e.vauleon@rennes.unicancer.fr
- Recruiting
Centre Henri Becquerel
Rouen, 76038
Maxime FONTANILLES, MD, 02 32 08 22 39, maxime.fontanilles@chb.unicancer.fr
- Not yet recruiting
CHU Saint-Etienne
Saint-Etienne, 42055
Carole RAMIREZ, MD, 06 62 13 37 01, carole.ramirez@chu-st-etienne.fr
- Recruiting
Institut de Cancerologie de l'Ouest
Saint-Herblain, 44805
Carole GOURMELON, MD, 02 40 67 99 00, carole.gourmelon@ico.unicancer.fr
- Recruiting
Centre de Lutte Contre le Cancer PAUL STRAUSS
Strasbourg, 67200
Georges NOEL, MD, PhD, 03 88 25 24 71, gnoel@icans.eu
- Not yet recruiting
Hôpital Foch
Suresnes, 92150
Nadia Younan, MD, 01 46 25 25 25, n.younan@hopital-foch.com
- Not yet recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
Elizabeth MOYAL, MD, PhD, 05 31 15 54 45, moyal.elizabeth@iuct-oncopole.fr
- Not yet recruiting
CHRU de Tours
Tours, 37044
Ilyess ZEMMOURA, MD, PhD, 02 18 37 08 13, ilyess.zemmoura@univ-tours.fr
- Not yet recruiting
Gustave Roussy
Villejuif, 94805
Sarah DUMONT, MD, 01 42 11 62 20, sarah.dumont@gustaveroussy.fr
About this study
Official title: A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
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.
- Being tested
- PCV chemotherapy, Radiotherapy and PCV chemotherapy
- Keywords
- low-grade oligodendroglioma, radiotherapy, PCV, neurocognitive deterioration
- Medical subject headings
- Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV chemotherapyDrug
- 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.
Radiotherapy and PCV chemotherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| PCV alone | Experimental | Administration of 6 cycles of PCV chemotherapy alone. Receives: Drug: PCV chemotherapy |
| RT + PCV | Active comparator | Radiotherapy followed by administration of PCV chemotherapy. Receives: Drug: Radiotherapy and PCV chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 9 years
Secondary outcomes (2)
Progression free survival
Time from study randomization to the time of progression of the tumor
Measured: During 9 years
Overall survival
Time from study randomization to the time of death
Measured: During 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start7 Dec 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligodendrogliomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702581
- Sponsor's protocol ID
- 69HCL20_0073
- Other IDs
- 2020-A02646-33
- Acronym
- POLO
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2021
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
- ClinicalTrials.gov ID
- NCT04702581
- Acronym / sponsor ID
- POLO / 69HCL20_0073
- Keywords
- low-grade oligodendroglioma, radiotherapy, PCV, neurocognitive deterioration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV alone | Experimental | Drug: PCV chemotherapyAdministration of 6 cycles of PCV chemotherapy alone. |
| RT + PCV | Active comparator | Drug: Radiotherapy and PCV chemotherapyRadiotherapy followed by administration of PCV chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV chemotherapy1. 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. | Drug | PCV alone |
| Radiotherapy and PCV chemotherapyRadiotherapy 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 | Drug | RT + PCV |
Primary outcome
Survival without neurocognitive deterioration
Time frame: During 9 years
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.
2 secondary outcomes
Progression free survival
Time frame: During 9 years
Overall survival
Time frame: During 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PCV chemotherapy and Radiotherapy and PCV chemotherapy in people with Oligodendroglioma and Low-grade Oligodendroglioma, run by Hospices Civils de Lyon at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François DUCRAY, MD, PhD (+33(0) 4 72 35 78 06, francois.ducray@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without neurocognitive deterioration (time frame: During 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.