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 :
- 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
- Overall survival defined as the duration of survival from the
randomization at 5 years.
- Rate of CTCAE (version 5.0) Grade 3 or more late radiation-related
adverse events.
- 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.