MRC TE08
Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group
- Population
- Patients with clinical stage I non-seminomatous germ-cell tumour of the testis who chose surveillance
- Design
- Randomised comparison of chest and abdominal CT scans at 3 and 12 months (two scans) versus 3, 6, 9, 12 and 24 months (five scans) in patients with clinical stage I NSGCT who opted for surveillance; all other investigations identical. Three of every five patients were allocated to the two-scan schedule; 400 patients were required. ISRCTN56475197.
- Arms
- Five CT scans (control, n = 167): Chest and abdominal CT at 3, 6, 9, 12 and 24 months
- Two CT scans (experimental, n = 247): Chest and abdominal CT at 3 and 12 months
- People
- Rustin GJ
Δ Relapse rate−5 pointsΔ Relapse with intermediate or poor prognosis+0.2 points
Show the numbers
| Endpoint | Analysis | Two CT scans | Five CT scans | Effect |
|---|---|---|---|---|
| Relapse rateRandomised patients | exploratorymedian follow-up 40 monthsRustin 2007 | 15% | 20% | 37 relapses in the two-scan arm and 33 in the five-scan arm. Descriptive: the primary comparison was the proportion relapsing with intermediate- or poor-prognosis disease. |
| Relapse with intermediate or poor prognosisRandomised patients | primarymedian follow-up 40 monthsRustin 2007 | 0.8% | 0.6% | Two patients in the two-scan arm and one in the five-scan arm had intermediate-prognosis disease at relapse; no patient had poor-prognosis disease and no deaths had been reported. Difference 0.2% (90% CI -1.2% to 1.6%). The authors state that an increase of more than 1.6% in intermediate- or poor-prognosis relapse with two scans can be ruled out with 95% probability. The percentages use all allocated patients as denominator (2/247 = 0.8%, 1/167 = 0.6%), not the patients who relapsed. |
| Endpoint | Analysis | Two CT scans | Five CT scans | Effect |
|---|---|---|---|---|
| Relapse rateRandomised patients | exploratorymedian follow-up 40 monthsRustin 2007 | 15% | 20% | 37 relapses in the two-scan arm and 33 in the five-scan arm. Descriptive: the primary comparison was the proportion relapsing with intermediate- or poor-prognosis disease. |
| Relapse with intermediate or poor prognosisRandomised patients | primarymedian follow-up 40 monthsRustin 2007 | 0.8% | 0.6% | Two patients in the two-scan arm and one in the five-scan arm had intermediate-prognosis disease at relapse; no patient had poor-prognosis disease and no deaths had been reported. Difference 0.2% (90% CI -1.2% to 1.6%). The authors state that an increase of more than 1.6% in intermediate- or poor-prognosis relapse with two scans can be ruled out with 95% probability. The percentages use all allocated patients as denominator (2/247 = 0.8%, 1/167 = 0.6%), not the patients who relapsed. |
Appears in
Sources
Rustin GJ, Mead GM, Stenning SP, Vasey PA, Aass N, Huddart RA, et al. Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group. J Clin Oncol. 2007;25(11):1310-5.