Study Protocol of the Bladder Adjuvant RadioTherapy (BART) Trial: A Randomised Phase III Trial of Adjuvant Radiotherapy Following Cystectomy in Bladder Cancer.

AIMS: To assess the efficacy and safety of adjuvant radiotherapy in patients with high-risk muscle-invasive bladder cancer (MIBC) following radical cystectomy (RC) and chemotherapy. MATERIALS AND METHODS: The BART (Bladder Adjuvant RadioTherapy) trial is an ongoing multicentric, randomised, phase III trial comparing the efficacy and safety of adjuvant radiotherapy versus observation in patients with high-risk MIBC. The key eligibility criteria include ≥pT3, node-positive (pN+), positive margins and/or nodal yield <10, or, neoadjuvant chemotherapy for cT3/T4/N+ disease. In total, 153 patients will be accrued and randomised, in a 1:1 ratio, to either observation (standard arm) or adjuvant radiotherapy (test arm) following surgery and chemotherapy. Stratification parameters include nodal status (N+ versus N0) and chemotherapy (neoadjuvant chemotherapy versus adjuvant chemotherapy versus no chemotherapy). For patients in the test arm, adjuvant radiotherapy to cystectomy bed and pelvic nodes is planned with intensity-modulated radiotherapy to a dose of 50.4 Gy in 28 fractions using daily image guidance. All patients will follow-up with 3-monthly clinical review and urine cytology for 2 years and subsequently 6 monthly until 5 years, with contrast-enhanced computed tomography abdomen pelvis 6 monthly for 2 years and annually until 5 years. Physician-scored toxicity using Common Terminology Criteria for Adverse Events version 5.0 and patient-reported quality of life using the Functional Assessment of Cancer Therapy - Colorectal questionnaire is recorded pre-treatment and at follow-up. ENDPOINTS AND STATISTICS: The primary endpoint is 2-year locoregional recurrence-free survival. The sample size calculation was based on the estimated improvement in 2-year locoregional recurrence-free survival from 70% in the standard arm to 85% in the test arm (hazard ratio 0.45) using 80% statistical power and a two-sided alpha error of 0.05. Secondary endpoints include disease-free survival, overall survival, acute and late toxicity, patterns of failure and quality of life. CONCLUSION: The BART trial aims to evaluate whether contemporary radiotherapy after standard-of-care surgery and chemotherapy reduces pelvic recurrences safely and also potentially affects survival in high-risk MIBC.

An audit and analysis of different causes of defaults in patients receiving radiation for head and neck cancers: A tertiary regional cancer center experience.

CONTEXT: Strict adherence and timely completion of the external beam radiation therapy (EBRT) schedule is an important prognostic factor in the survival of head and neck cancer patients. However, many patients are unable to complete the radiation treatment due to various reasons resulting in a poor outcome. AIMS: This study aims to study the pattern and various possible causes of defaults for possible intervention. SETTINGS AND DESIGN: A retrospective epidemiological analysis. SUBJECTS AND METHODS: Patients receiving EBRT for head and neck cancers with curative intent from January 2015 to December 2015 but did not complete the prescribed treatment were included. Unplanned treatment breaks in the treatment was not taken into consideration. STATISTICAL ANALYSIS USED: SPSS version 21. RESULTS: Out of 458, 92 (20.08%) patients did not complete the EBRT (P = 0.06). Fifty-six out of total 92 patients (60.9%) who defaulted stopped taking treatment within halfway of the treatment (15 fraction) and 12 out of total 92 patients (13%) just at the 22nd/23rd fraction. Defaulter rates in patients from different places are in the range of 12.8% to 33.0% but was statistically not significant (P = 0.224). There was no particular age (P = 0.966), disease site (P = 0.354) preponderance among defaulters. Use of concurrent chemo-radiation in radical or adjuvant settings was also not related to defaults (P = 0.406). CONCLUSIONS: Radiation-induced acute toxicity, socioeconomic status and distance plays minimal role as a cause of patients who stop taking EBRT. There is no particular relation between age, disease site, treatment received before radiotherapy, intent of treatment, and concurrent chemoradiation-induced acute reactions with defaults among patients. Loss of income and work in the poor population during the treatment may be an important possible cause of defaults.