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New treatment option for Oligodendroglioma
Official title A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
ClinicalTrials.gov ID: NCT04702581
What this study is testing
What is PCV chemotherapy?
PCV chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oligodendroglioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Bordeaux, France
- Brest, France
- Bron, France
- Caen, France
- Clamart, France
- Colmar, France
- Dijon, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nice, France
- Paris, France
- Pringy, France
- Rennes, France
- Rouen, France
- Saint-Etienne, France
- Saint-Herblain, France
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Bordeaux, France; Brest, France; Bron, France; Caen, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.