Table 1.
Randomised controlled trials | |||||||
Study | n | Stage | Radiosensitiser | Protocol | Radiotherapy | CR rate | Results |
James et al. 2012 [18] | 360 | T2-T4a N0 | Mitomycin and 5-Fluorouracil | Concomitant chemoradiotherapy (5-fluorouracil-mitomycin) Versus Radiotherapy alone | 64 Gy in 32 fractions over 6.5 weeks or 52.5 Gy in 20 fractions over 4 weeks to the Bladder | – | OS (5 years): 48% Vs 35% (p = 0.16)CSS (2 years): 67% Vs 54% (p = 0.03) |
Hoskins et al. 2010 [19] | 333 | T2-T4aT1G3 | Carbogen plus Nicotinamide | Radiotherapy + nicotinamide Versus Radiotherapy alone | 64 Gy in 32 fractions over 6.5 weeks or 55 Gy in 20 fractions over 4 weeks to the Bladder | 81% vs 76% (p = 0.3) | OS (3 years): 59% Vs 46% (p = 0.04)CSS (3 years): 54% Vs 43% (p = 0.06) |
Coppin et al. 1996 [21] | 99 | T2-T4b N0 | Cisplatin | Radiotherapy alone versus Radiotherapy with concurrent cisplatin | 40 Gy in 20 fractions over 4 weeks to the pelvis followed by 20 Gy in 10 fractions over 2 weeks to the bladder | 47% vs 31% | OS (3 years): 47% Vs 33% (NS)LRR rate (5 years): 40 Vs 59% (p = 0.04) |
Housset et al. 1993 [8] | 54 | T2-T4a N0/N1 | Concurrent chemoradiation (cisplatin + 5-fluorouracil) | 24 Gy in 8 fractions to the pelvis over 17 days, 2 fractions per day followed by 20 Gy to the bladder in 8 fractions over 17 days, 2 fractions per day | 74% | Overall survival (3 years) 59% specific survival (3 years): 62% | |
List of non randomised trials | |||||||
Study | n | Stage | Radiosensitiser | Protocol | CR rate | Result | |
RTOG 85-12 1993 [10] | 47 | T2-4, N0-2/Nx | Concurrent chemoradiation (cisplatin) | 40 Gy in 20 fractions to the pelvis over 4 weeks with cisplatin day 1 and 21 followed by 24 Gy in 12 fractions to the bladder over 2.5 weeks with 3rd dose of cisplatin | 66% | Overall survival (3 years): 64% radical cystectomy: 21% | |
RTOG 95-06, 2000 [11] | 34 | T2-T4a N0/Nx | Concurrent chemoradiation (cisplatin + 5-fluorouracil) | 24 Gy in 8 fractions to the pelvis over 17 days, 2 fractions per day followed by 20 Gy to the bladder in 8 fractions over 17 days, 2 fractions per day | 67% | Overall survival (3 years): 83% radical cystectomy: 29% | |
RTOG 97-06, 2003 [9] | 47 | T2-T4a, N0 | Concomitant chemoradiotherapy (cisplatin) + adjuvant chemotherapy (CMV) | 40.8 Gy in 12 fractions to the bladder and 21.6 Gy in 12 fractions to the pelvis followed by consolidation of 24 Gy in 16 fractions over 10 days with two fractions per day | 74% | Overall survival (3 years): 61% radical cystectomy: 25% |
n: number of participants; CR: complete response; OS: overall survival; CSS: Cause specific survival; NS: non significant.