MRC TE10
Optimal planning target volume for stage I testicular seminoma: A Medical Research Council randomized trial. Medical Research Council Testicular Tumor Working Group
N = 478
- Population
- Men with stage I (T1 to T3) testicular seminoma, no ipsilateral inguinoscrotal operation before orchiectomy
- Design
- Randomised comparison of para-aortic (PA) strip versus para-aortic plus ipsilateral iliac node (dogleg, DL) irradiation, both 30 Gy in 15 fractions over 3 weeks, July 1989 to May 1993. The mature pooled analysis states that the trial was not powered to exclude clinically relevant differences in overall relapse rates.
- Arms
- Dogleg field (control, n = 242): Radiotherapy to para-aortic and ipsilateral iliac nodes, 30 Gy in 15 fractions over 3 weeks
- Para-aortic strip (experimental, n = 236): Radiotherapy to para-aortic nodes only, 30 Gy in 15 fractions over 3 weeks
- People
- Fosså SD, Medical Research Council Testicular Tumor Working Group
Δ 36-month RFR−0.6 pointsΔ 36-month OS−0.7 pointsRelapse rateHR 1.15
Show the numbers
| Endpoint | Analysis | Para-aortic strip | Dogleg field | Effect |
|---|---|---|---|---|
| RFRRandomised menCalled relapse-free survival in the abstract. | primarymedian follow-up 4.5 yearsFosså 1999 | 96% at 3 y (94–99%) | 96.6% at 3 y (94–99%) | Eighteen relapses, nine in each group, 4 to 35 months after radiotherapy; four were pelvic relapses, all after para-aortic radiotherapy, though the 95% CI for the difference in pelvic relapse rates excludes differences of more than 4%. The difference in 3-year relapse-free survival was 0.6% (95% confidence limits -3.4% to +4.6%). |
| OSRandomised men | exploratorymedian follow-up 4.5 yearsFosså 1999 | 99.3% at 3 y | 100% at 3 y | Overall survival at 3 years; not a stated primary endpoint. One patient (PA field) died from seminoma. |
| Relapse rateRandomised men | long term-updateMead 2011 | — | — | HR 1.15Hazard ratio of relapse 1.15 with a 90% confidence interval of 0.54 to 2.44 attributed in the abstract to para-aortic radiotherapy (the comparator is the dogleg field by trial design), from the pooled 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). The abstract states that TE10 was not powered to exclude clinically relevant differences in overall relapse rates. |
| Endpoint | Analysis | Para-aortic strip | Dogleg field | Effect |
|---|---|---|---|---|
| RFRRandomised menCalled relapse-free survival in the abstract. | primarymedian follow-up 4.5 yearsFosså 1999 | 96% at 3 y (94–99%) | 96.6% at 3 y (94–99%) | Eighteen relapses, nine in each group, 4 to 35 months after radiotherapy; four were pelvic relapses, all after para-aortic radiotherapy, though the 95% CI for the difference in pelvic relapse rates excludes differences of more than 4%. The difference in 3-year relapse-free survival was 0.6% (95% confidence limits -3.4% to +4.6%). |
| OSRandomised men | exploratorymedian follow-up 4.5 yearsFosså 1999 | 99.3% at 3 y | 100% at 3 y | Overall survival at 3 years; not a stated primary endpoint. One patient (PA field) died from seminoma. |
| Relapse rateRandomised men | long term-updateMead 2011 | — | — | HR 1.15Hazard ratio of relapse 1.15 with a 90% confidence interval of 0.54 to 2.44 attributed in the abstract to para-aortic radiotherapy (the comparator is the dogleg field by trial design), from the pooled 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). The abstract states that TE10 was not powered to exclude clinically relevant differences in overall relapse rates. |
Appears in
Sources
Fosså SD, Horwich A, Russell JM, Roberts JT, Cullen MH, Hodson NJ, et al. Optimal planning target volume for stage I testicular seminoma: A Medical Research Council randomized trial. Medical Research Council Testicular Tumor Working Group. J Clin Oncol. 1999;17(4):1146.
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.