MRC TE18 / EORTC 30942
Needs reviewRandomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I Testicular Seminoma: a report on Medical Research Council Trial TE18, European Organisation for the Research and Treatment of Cancer Trial 30942 (ISRCTN18525328)
N = 625
- Population
- Men with stage I testicular seminoma after orchidectomy
- Design
- Randomised comparison of 20 Gy in 10 fractions over 2 weeks versus 30 Gy in 15 fractions over 3 weeks after orchidectomy, 1995 to 1998. Patients completed symptom diary cards during treatment and quality-of-life forms before and after. Powered to exclude absolute differences in 2-year relapse rates of 3% to 4% (one-sided alpha .05, 90% power).
- Arms
- 30 Gy (control): Adjuvant radiotherapy, 30 Gy in 15 fractions over 3 weeks
- 20 Gy (experimental): Adjuvant radiotherapy, 20 Gy in 10 fractions over 2 weeks
- People
- Jones WG
Relapse rateHR 1.11Δ Moderate or severe lethargy at 4 weeks−15 pointsΔ Unable to work normally at 4 weeks−18 pointsRelapse rateHR 0.63
Show the numbers
| Endpoint | Analysis | 20 Gy | 30 Gy | Effect |
|---|---|---|---|---|
| Relapse rateRandomised men | primarymedian follow-up 61 monthsJones 2005 | — | — | HR 1.11Ten relapses in the 30-Gy group and 11 in the 20-Gy group. Hazard ratio 1.11 with a 90% confidence interval of 0.54 to 2.28, as published. The absolute difference in 2-year relapse rates is 0.7%; the abstract gives 2.9% as the 'lower 90% confidence limit' (wording as published). Only one patient died from seminoma (allocated to 20 Gy). |
| Moderate or severe lethargy at 4 weeksPatients reporting on symptom diary cards (the number completing them is not stated in the abstract) | exploratoryJones 2005 | 5% | 20% | Symptom comparison at 4 weeks; the trial was powered for relapse. Levels in the two groups were similar by 12 weeks. |
| Unable to work normally at 4 weeksPatients reporting on symptom diary cards (the number completing them is not stated in the abstract) | exploratoryJones 2005 | 28% | 46% | Symptom comparison at 4 weeks; the trial was powered for relapse. Levels in the two groups were similar by 12 weeks. |
| Relapse rateTE18 as counted in the Mead 2011 combined analysis (1094 patients; the original report randomised 625; the difference is not explained in the abstract) | long term-updateMead 2011 | — | — | HR 0.63Hazard ratio of relapse 0.63 with a 90% confidence interval of 0.38 to 1.04, attributed in the abstract to 20 Gy (comparator 30 Gy by trial design), from the Mead 2011 combined analysis of TE10, TE18 and TE19 (median follow-up 6.4 to 12 years across the three trials; trial-specific value not given in the abstract). Noninferiority required the upper limit of the 90% CI to exclude a hazard ratio above 2.0 and a doubling of the 5-year relapse rate in the control arm. The abstract counts 1094 patients for TE18, whereas the original report randomised 625; this is not reconciled here. |
| Endpoint | Analysis | 20 Gy | 30 Gy | Effect |
|---|---|---|---|---|
| Relapse rateRandomised men | primarymedian follow-up 61 monthsJones 2005 | — | — | HR 1.11Ten relapses in the 30-Gy group and 11 in the 20-Gy group. Hazard ratio 1.11 with a 90% confidence interval of 0.54 to 2.28, as published. The absolute difference in 2-year relapse rates is 0.7%; the abstract gives 2.9% as the 'lower 90% confidence limit' (wording as published). Only one patient died from seminoma (allocated to 20 Gy). |
| Moderate or severe lethargy at 4 weeksPatients reporting on symptom diary cards (the number completing them is not stated in the abstract) | exploratoryJones 2005 | 5% | 20% | Symptom comparison at 4 weeks; the trial was powered for relapse. Levels in the two groups were similar by 12 weeks. |
| Unable to work normally at 4 weeksPatients reporting on symptom diary cards (the number completing them is not stated in the abstract) | exploratoryJones 2005 | 28% | 46% | Symptom comparison at 4 weeks; the trial was powered for relapse. Levels in the two groups were similar by 12 weeks. |
| Relapse rateTE18 as counted in the Mead 2011 combined analysis (1094 patients; the original report randomised 625; the difference is not explained in the abstract) | long term-updateMead 2011 | — | — | HR 0.63Hazard ratio of relapse 0.63 with a 90% confidence interval of 0.38 to 1.04, attributed in the abstract to 20 Gy (comparator 30 Gy by trial design), from the Mead 2011 combined analysis of TE10, TE18 and TE19 (median follow-up 6.4 to 12 years across the three trials; trial-specific value not given in the abstract). Noninferiority required the upper limit of the 90% CI to exclude a hazard ratio above 2.0 and a doubling of the 5-year relapse rate in the control arm. The abstract counts 1094 patients for TE18, whereas the original report randomised 625; this is not reconciled here. |
Appears in
Sources
Jones WG, Fossa SD, Mead GM, Roberts JT, Sokal M, Horwich A, et al. Randomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I Testicular Seminoma: a report on Medical Research Council Trial TE18, European Organisation for the Research and Treatment of Cancer Trial 30942 (ISRCTN18525328). J Clin Oncol. 2005;23(6):1200-8.
Mead GM, Fossa SD, Oliver RT, Joffe JK, Huddart RA, Roberts JT, et al. Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst. 2011;103(3):241-9.