The Absolute Effect / Evidence / MRC TE19 / EORTC 30982
Germ Cell Tumours · Medical Oncology · Stage I Seminoma

MRC TE19 / EORTC 30982

Clinical question

In stage I seminoma, can single-dose carboplatin replace adjuvant radiotherapy?

Trial context
Population
1,447 men with stage I seminoma after radical inguinal orchiectomy
Intervention
Single-dose carboplatin vs adjuvant radiotherapy
Key endpoint
5-year relapse-free rate
Time horizon / follow-up
5 years
Absolute Effect

What changes for patients?

At 5 years, relapse-free rate was 94.7% with single-dose carboplatin versus 96.0% with radiotherapy. The reported absolute difference is 1.3 percentage points in favour of RT; this is a non-inferiority comparison, not evidence that carboplatin is superior. The trial’s non-inferiority criterion was met (HR 1.25; 90% CI 0.83–1.89). Do not interpret this as a 1.3% difference in overall survival.

Contralateral testicular germ-cell tumours occurred in 2 patients assigned carboplatin versus 15 assigned RT (HR 0.22; 95% CI 0.05–0.95). These are event counts, not an NNT calculation; the randomized allocation was unequal (573 vs 904).

NNT: Not applicable as a routine summary for this non-inferiority comparison; report the absolute endpoint difference and trial design instead.

Treatment burden / harm

Treatment burden and fatigue

NNH: Not quantifiable from the primary publication; carboplatin had less lethargy and less time off work than RT, while acute and late toxicities were otherwise reported descriptively

Relative effect

NON-INFERIOR; HR: 1.25 for relapse with carboplatin vs RT

90% CI 0.83–1.89; non-inferiority margin excluded a doubling of relapse risk

Clinical interpretation · Current practice context

This is a historical randomized comparison, not a complete statement of current stage I seminoma management. Contemporary guidance generally favours active surveillance after orchiectomy when reliable follow-up is feasible. If adjuvant treatment is selected, one dose of carboplatin at AUC 7 is an option; adjuvant radiotherapy is not routinely recommended and is reserved for selected patients. Thus, the practical decision today is usually surveillance versus selected adjuvant carboplatin—not simply carboplatin versus RT.

Guideline context checked 12 October 2026. The trial results above remain the randomized evidence; current recommendations are a separate layer of interpretation.

Sources · Trial and current guidance

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