Brain cancer, oligodendroglioma Cancer
Conditions
Interventions
The APPROACH trial is a Phase III, multicentre trial. Patients will be recruited from 18-25 centres and randomised 1:1 between photon radiotherapy (RT) and proton beam therapy (PBT), delivered over ap
assuming a common standard deviation (SD) of 1 this effect size equates to a mean z-score of 0.5, and is deemed clinically relevant in this setting given that patients are typically young and of worki
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
25 Years to 110 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognitive function (NCF) at 5 years measured using the standard neurocognitive test battery - EORTC core clinical trial battery composite (CTB COMP) during baseline and at 1, 3, 6, 12, 24, 36, 48 and 60 months post end of RT, as per standard follow-up schedules | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Additional tests of neurocognitive function measured using the CNS Vital Signs test battery (Verbal Memory (VBM), Visual Memory (VIM), Finger Tapping (FTT), Symbol Digit Coding (SDC), Stroop Test (ST), Shifting Attention (SAT), Continuous Performance (CPT), Perception of Emotion (POET), On-Verbal Reasoning (NVRT), and the 4-part Continuous Performance (FPCPT)) at baseline, and 1, 12, 24, 36, 48 and 60 months post-RT 2. Health-Related Quality of Life (HRQoL) measured using the EORTC Quality of life questionnaire core 30 (QLQ-C30), QLQ-BN20, the EuroQol EQ-5D-5L, and Multidimensional Fatigue Inventory (MFI) questionnaire and the Hospital Anxiety and Depression Scale (HADS) at baseline, during the final week of RT and at 1, 3, 6, 12, 24, 36, 48, 60 months post-RT 3. Endocrinopathy measured using dynamic/static testing in blood for GH/IGF-1, FSH/LH/testosterone (males) and SHBG (males)/oestradiol (females), cortisol, T4/T3/TSH, and prolactin at baseline and at 6, 12, 24, 36, 48 and 60 months post-RT, as per standard of care 4. Treatment compliance measured using patient records with data on the treatment participants receive collected weekly during radiotherapy 5. Work and economic impact measured using the WPAI general health (WPAI: GH) questionnaire completed by the participant and their primary caregivers at baseline, during the final week of RT and at 1, 3, 6, 12, 24, 36, 48 and 60 months post-RT 6. Caregiver distress measured using the 30-item Caregiver Needs Screen completed by the participant’s primary caregiver at baseline, during the final week of RT and at 1, 3, 6, 12, 24, 36, 48, and 60 months post-RT 7. Early (acute) and late toxicity: acute toxicity period, defined from the start of RT to the 3 months post end of RT follow-up assessment, measured by clinician assessment each week of treatment during clinic and during the 1 and 3 month follow-up assessments; late toxicity period, defined as after 3 months until the final follow-up visit at 60 months, mea | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactJaike Belgrave
Outcome results
None listed