High-risk non-muscle invasive bladder cancer Cancer
Conditions
Interventions
This trial is an unblinded randomised Phase III trial. Patients will randomly be allocated to one of two trials arms. The first arm (control) is the current standard of care for this patient group whi
Sponsors
The Christie NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with histologically confirmed grade 3 T1N0M0 transitional cell carcinoma, or carcinoma in situ of the bladder (and N0M0), or both, with detrusor muscle present in the biopsy specimen if T1 disease (or a repeat resection that does contain muscle that is clear) 2. Suitable for BCG treatment 3. Suitable for radiotherapy and radiosensitisation according to the schedule of administration outline in the Radiotherapy Planning Guidance document 4. Life expectancy over 12 months 5. ECOG performance status 0 - 2 6. Age >16 years 7. Provided written informed consent
Exclusion criteria
Exclusion criteria: 1. MDT selected patients with HR-NMIBC who are deemed best suited for primary cystectomy (patients that have trained have had this treatment recommendation but then decline cystectomy remain eligible for TRAIN) 2. Previous radiotherapy to the pelvis 3. Previous intravesical therapy 4. Poor bladder function (IPSS >16) 5. A recent or current other cancer. Current non-melanoma skin cancer, cervical carcinoma in situ or localised prostate cancer not requiring current treatment are permissible, as is a history of a separate other malignancy having completed all active treatment =2 years previously and without evidence of relapse 6. Pre-existing medical conditions that preclude treatment options in either trial arm 7. Patient currently recruited to another interventional trial or participation within an interventional clinical trial within 3 months of the point of registration within TRAIN 8. Pregnant or breastfeeding 9. Not able to use appropriate adequate effective contraception during and for 3 months after the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival, defined as time from randomisation to any of: CIS or high-risk G3 non-muscle invasive papillary tumour recurrence, progression to muscle invasive disease, distant metastatic bladder cancer, cystectomy (for any reason), or death from any cause. Patients will be censored at the point of last follow up where an event has not occurred. Cystoscopies will be every 3-4 months as per standard of care and in accordance with NICE guidelines to capture progression and recurrence data. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrence-free survival: time from randomisation to recurrence or end of trial 2. Progression-free survival: time from randomisation to progression or end of trial 3. Metastasis-free survival: time from randomisation to metastasis or end of trial 4. Cancer-specific survival: time from randomisation to cancer diagnosis or end of trial 5. Cystectomy-free survival: time from randomisation to cystectomy or end of trial 6. Overall survival: time from randomisation to death or end of trial 7. Treatment fidelity measured using the summary statistics for treatment delays, missed treatment, those not starting treatment, and those who completed treatment, by group at end of treatment 8. Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) v5 at 24 weeks 9. Cost-effectiveness measured using Modular Resource-Use Measure (ModRUM) at 96 weeks 10. Late radiation morbidity of the bladder and intestines measured using Radiation Therapy Oncology Group (RTOG) at 96 weeks 11. Patient-reported outcomes: 11.1. Quality of life and the cost-effectiveness measured using EQ-5D at baseline, then 12, 24, 36,48,60, 72, 84 and 96 weeks from initiation of treatment 11.2. Quality of life measured using the International Prostate Symptom Score (IPSS) at baseline, then 12, 24, 36,48,60, 72, 84 and 96 weeks from initiation of treatment then every 6 months until the end of study 11.3. Quality of life measured using the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC-QLQ-C30) at baseline, then 12, 24, 36,48,60, 72, 84 and 96 weeks from initiation of treatment 11.4. Quality of life measured using EORTC-QLQ-NMIBC24 at baseline, then 12, 24, 36,48,60, 72, 84 and 96 weeks from initiation of treatment | — |
Countries
England, United Kingdom
Outcome results
None listed