Medical Research Council prospective study of surveillance for stage I testicular teratoma. Medical Research Council Testicular Tumors Working Party
Phase observationalN = 373
- Population
- Men with stage I non-seminomatous germ-cell testicular tumour managed by surveillance after orchidectomy
- Design
- Prospective multicentre study of surveillance after orchidectomy alone: 396 patients from 16 United Kingdom centres and one Norwegian centre were entered between 1 January 1984 and 1 October 1987, of whom 373 were eligible for analysis. Aim: to determine the relapse-free rate and identify histological criteria predicting relapse. A prognostic index from an earlier retrospective study used venous and lymphatic invasion, undifferentiated cells and absence of yolk sac elements.
- Arms
- Surveillance (experimental, n = 373): Orchidectomy alone, then surveillance
- People
- Read G, Medical Research Council Testicular Tumors Working Party
Show the numbers
| Endpoint | Analysis | Surveillance | Control | Effect |
|---|---|---|---|---|
| RFREligible patients | primaryRead 1992 | 75% at 2 y (71–79%); 73% at 5 y | — | Actuarial relapse-free rate after orchidectomy. |
| RFREligible patients with three or four risk factors of the histological prognostic index | exploratoryRead 1992 | 54% | — | The abstract does not state the time point for this rate. |
| OSEligible patients | primaryRead 1992 | 98% at 5 y | — | Five patients died of tumour or treatment-related complications. |
| Endpoint | Analysis | Surveillance | Control | Effect |
|---|---|---|---|---|
| RFREligible patients | primaryRead 1992 | 75% at 2 y (71–79%); 73% at 5 y | — | Actuarial relapse-free rate after orchidectomy. |
| RFREligible patients with three or four risk factors of the histological prognostic index | exploratoryRead 1992 | 54% | — | The abstract does not state the time point for this rate. |
| OSEligible patients | primaryRead 1992 | 98% at 5 y | — | Five patients died of tumour or treatment-related complications. |
- Surveillance (experimental)
Data table (modelled values)
| Months | Surveillance |
|---|---|
| 0 | 100.0% |
| 16 | 80.2% |
| 32 | 74.0% |
| 49 | 73.1% |
| 65 | 73.0% |