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

January 28, 2026 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
      • Angers, France, 49055
      • Bordeaux, France, 33075
      • Brest, France, 29200
        • Recruiting
        • Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan
        • Contact:
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Contact:
        • Principal Investigator:
          • François DUCRAY, MD, PhD
      • Caen, France, 14033
        • Not yet recruiting
        • CHU de Caen
        • Contact:
      • Clamart, France, 92141
        • Not yet recruiting
        • Hopital D'Instruction Des Armees Percy
        • Contact:
      • Colmar, France, 68024
        • Not yet recruiting
        • Hôpital Pasteur - Hôpitaux civils de Colmar
        • Contact:
      • Dijon, France, 21000
        • Not yet recruiting
        • Centre Georges François Leclerc
        • Contact:
      • Lille, France, 59037
        • Recruiting
        • Hôpital Roger Salengro CHU de Lille
        • Contact:
      • Limoges, France, 87042
      • Lyon, France, 69008
      • Marseille, France, 13005
        • Recruiting
        • Hôpital Timone
        • Contact:
      • Nice, France, 06000
        • Not yet recruiting
        • CHU de Nice Hopital Pasteur
        • Contact:
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis, AP-HP
        • Contact:
      • Paris, France, 75651
        • Recruiting
        • GH Pitié Salpêtrière
        • Contact:
      • Pringy, France, 74374
        • Not yet recruiting
        • CH Annecy Genevois site Annecy
        • Contact:
      • Rennes, France, 35042
      • Rouen, France, 76038
      • Saint-Etienne, France, 42055
      • Saint-Herblain, France, 44805
      • Strasbourg, France, 67200
        • Recruiting
        • Centre de lutte contre le cancer Paul Strauss
        • Contact:
          • Georges NOEL, MD, PhD
          • Phone Number: 03 88 25 24 71
          • Email: gnoel@icans.eu
      • Suresnes, France, 92150
      • Toulouse, France, 31059
        • Not yet recruiting
        • Institut Universitaire du Cancer Toulouse Oncopole
        • Contact:
      • Tours, France, 37044
      • Villejuif, France, 94805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

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 (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCV alone
Administration of 6 cycles of PCV chemotherapy alone.
Drug: PCV chemotherapy

  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.
Active Comparator: RT + PCV
Radiotherapy followed by administration of PCV chemotherapy.
Drug: Radiotherapy and PCV chemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During 9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: During 9 years
Time from study randomization to the time of progression of the tumor
During 9 years
Overall survival
Time Frame: During 9 years
Time from study randomization to the time of death
During 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0073
  • 2020-A02646-33 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oligodendroglioma

Clinical Trials on PCV chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe