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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04702581
Collaborator
(none)
280
Enrollment
26
Locations
2
Arms
107.8
Anticipated Duration (Months)
10.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: PCV chemotherapy
  • Drug: Radiotherapy and PCV chemotherapy
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
Actual Study Start Date :
Dec 7, 2021
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

ArmIntervention/Treatment
Experimental: PCV alone

Administration of 6 cycles of PCV chemotherapy alone.

Drug: PCV chemotherapy
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

Outcome Measures

Primary Outcome Measures

  1. Survival without neurocognitive deterioration [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.

Secondary Outcome Measures

  1. Progression free survival [During 9 years]

    Time from study randomization to the time of progression of the tumor

  2. Overall survival [During 9 years]

    Time from study randomization to the time of death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHU d'Amiens-Picardie Site SudAmiensFrance80054
2Institut de Cancerologie de l'OuestAngersFrance49055
3CHU de Bordeaux Hôpital Saint AndréBordeauxFrance33075
4Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital MorvanBrestFrance29200
5Hospices Civils de LyonBronFrance69500
6CHU de CaenCaenFrance14033
7Hôpital d'Instruction des Armées PERCYClamartFrance92141
8Hôpital Pasteur - Hôpitaux civils de ColmarColmarFrance68024
9Centre Georges Francois LeclercDijonFrance21000
10Hôpital Roger Salengro CHU de LilleLilleFrance59037
11CHU de LimogesLimogesFrance87042
12Centre Léon BérardLyonFrance69008
13Hôpital TimoneMarseilleFrance13005
14CHU de Nice Hôpital PasteurNiceFrance06000
15Hôpital Saint-Louis, AP-HPParisFrance75010
16GH Pitié SalpêtrièreParisFrance75651
17CH Annecy Genevois site AnnecyPringyFrance74374
18Centre Eugène MarquisRennesFrance35042
19Centre Henri BecquerelRouenFrance76038
20Institut de Cancerologie de l'OuestSaint-HerblainFrance44805
21CHU Saint-EtienneSaint-ÉtienneFrance42055
22Institut de Cancérologie Strasbourg EuropeStrasbourgFrance67200
23Hôpital FochSuresnesFrance92150
24Institut Universitaire du Cancer Toulouse OncopoleToulouseFrance31059
25CHRU de ToursToursFrance37044
26Gustave RoussyVillejuifFrance94805

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04702581
Other Study ID Numbers:
  • 69HCL20_0073
  • 2020-A02646-33
First Posted:
Jan 11, 2021
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2022