Table 1.
Primary and secondary outcomes in six phase III RCTs of chemoradiotherapy in patients with anal cancer.
| Trial (year of publication) | Local treatment failure | Progression-free survival | Disease-free survival | Colostomy-free survival | Colostomy | Acute toxicity | Overall survival | Cancer-specific survival | Local/Regional control |
|---|---|---|---|---|---|---|---|---|---|
| ACT I (1996) | P1 | S | S | S | |||||
| EORTC (1997) | P1 | S | S | S | |||||
| RTOG 87–04 (1996) | P2 | S | S | S | S | S | S | ||
| RTOG 98–11 (2008) | P | S | S | S | S | ||||
| ACCORD-03 (2012) | P | S | S | S | |||||
| ACT II (2013) | P3 | P | S | P | S | S | S |
P, primary outcome; S, secondary outcome.
Definition of local treatment failure: 1, clinically, at 6 weeks; 2, on biopsy, post-irradiation; 3, clinically, at 26 weeks.