The neurocognitive benefits of proton beam therapy for patients with oligodendroglioma

Not Applicable

• Conditions: Brain cancer, oligodendroglioma; Cancer

• Registration Number: ISRCTN13390479
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-21
• Last Update Posted: 12 February 2024
• Study Completion: 2031-07-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

1. Histologically proven diagnosis of oligodendroglioma (ODG) with 1p19q co-deletion and isocitrate dehydrogenase (IDH) mutation
2. Randomisation must be performed within 28 days of the magnetic resonance imaging (MRI) that leads to the decision that radiotherapy (RT) is required at that point in time. Outside of 28 days, an updated MRI is required to serve as a contemporaneous baseline scan to assess response to further treatment.
3. Karnofsky Performance Status (KPS) =70%.
4. Adequate wound healing and recovery if recent surgery.
5. Suitable to complete baseline neurocognitive testing (No access to translated tests, can only be administered in English).
6. Patients of childbearing potential should be asked to confirm that they are not pregnant to confirm trial eligibility. Formal Pregnancy testing should be performed if there is any doubt as to pregnancy status or if felt appropriate, including in circumstances such as irregular periods, unprotected sexual intercourse since the last menstrual period, missed contraceptive pill or antibiotics during the last menstrual cycle or failure of barrier contraception.
7. Fertile participants, born male, must agree to practice methods of contraception that are considered medically acceptable for the duration of RT, adjuvant chemotherapy and for 6 months post-end of treatment if sexually active with a person of child-bearing potential.
8. Able to swallow oral medication.
9. Able to provide study-specific informed consent.
10. Age 25 or above at the point of starting RT treatment.
11. No known haematological, renal or hepatic impairments making PCV chemotherapy inappropriate

Exclusion Criteria

1. Pregnancy (positive pregnancy test) or lactating.
2. Prior cranial or head and neck radiotherapy (RT).
3. Any previous chemotherapy for the treatment of oligodendroglioma (ODG).
4. Comorbid neurodegenerative diseases that influence neurocognitive function (NCF).
5. Severe active co-morbidity making patient unsuitable for RT and/ or adjuvant chemotherapy (e.g., uncontrolled diabetes, uncontrolled hypertension).
6. Leptomeningeal disease.
7. Spinal or infratentorial disease.
8. Another currently active malignancy or another malignancy within the last 3 years.
9. Any contra-indication to procarbazine, vincristine or lomustine including: coeliac disease; the rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
10. Any recognised genetic syndrome causing sensitivity to radiotherapy.
11. Patient unwilling/ unable to attend for follow up in the local radiotherapy centre.
12. Contraindication to MRI or gadolinium.

Study & Design

• Study Type: Interventional
• Study Design: Not specified