Objectives {7}

We hypothesize that the locoregional recurrence rate after a one-week (5 fractions) course of adjuvant radiotherapy will be non-inferior to the standard three-week course (15 fractions). The primary objective is to compare the cumulative proportion of patients experiencing a locoregional recurrence by 5 years between one week and three-week course of radiotherapy. Based on an audit of the outcomes of patients treated at our centre, the cumulative proportion of the locoregional recurrence rate in the control arm is expected to be 5% at 5 years. A non-inferiority boundary of 3% would be clinically acceptable in this setting.
The secondary objectives are to compare :
  1. Invasive disease-free survival, defined as the duration of time from randomization to disease recurrence, death due to any cause, or any second invasive malignancy at 5 years
  2. Overall survival defined as the duration of survival from the randomization at 5 years.
  3. Rate of CTCAE (version 5.0) Grade 3 or more late radiation-related adverse events.
  4. The proportion of patients with health-related quality of life(QoL) similar to or better than the baseline at 12 months.

Trial Design {8}

The HYPORT-Adjuvant trial is an investigator-driven, open-label, parallel-group, two-arm, non-inferiority, randomized controlled trial of 10-year total duration. Patients will be accrued for 5 years in this trial and allocated equally in the two arms. Figure 1 shows the trial schema.