Table 1. Details and results of certain phase III studies.
Trial | Recruitment | Stage | N patients | Total dose/fraction size (Gy) | RT technique | Local recurrence rate (%) | P | 5-year survival rate (%) | P |
---|---|---|---|---|---|---|---|---|---|
Belgium (6)* | 1966-1977 | I, II (N0) | 104 | – | – | 10.90 | ns | 43 | <0.05 (no PORT) |
98 | 60/2 | Cobalt | 1.20 | 24 | |||||
LCSG (12) | 1978-1985 | II, III | 120 | – | – | 41 | 0.001 | 40 | ns |
110 | 50.4/1.8 | Cobalt and Linac | 3 | 40 | |||||
CAMS (11) | 1981-1995 | II, III | 182 | – | – | 33.20 | 0.01 | 40.5 | ns |
183 | 60/2 | Cobalt and Linac | 12.70 | 42.9 | |||||
Lille (10)* | 1985-1991 | I | 72 | – | – | na | ns | 51.6 | ns |
60 | 45-60/2 | Cobalt and Linac | na | 35.2 | |||||
GETCB (7) [86 and 88] | 1986-1994 | I, II, III | 355 | – | – | 34 | ns | 43 | 0.002 (no PORT) |
373 | 60/2-2.5 | Cobalt and Linac | 28 | 30 | |||||
Italy (15)* | 1989-1997 | I | 53 | – | – | 23 | 0.019 | 58 | 0.048 (PORT)** |
51 | 50.4/1.8 | Linac | 2.20 | 67 | |||||
Austria (16) | I, II, III | 72 | – | – | 20 | <0.01 | 20.4 | ns | |
83 | 50-56/2 | Linac | 7 | 29.7 |
*, pN0 patients; **, this result was no longer significant when updated (14)