Orchidectomy alone versus orchidectomy plus radiotherapy in stage I nonseminomatous testicular cancer: a randomized study by the Danish Testicular Carcinoma Study Group.

All Danish patients with stage I nonseminomatous testicular cancer diagnosed between December 1980 and January 1984 entered a randomized study comparing irradiation of retroperitoneal lymph nodes with surveillance only after orchidectomy. Twenty-four of the seventy-nine patients in the observation-only group have relapsed, three patients relapsing more than 2 years after orchidectomy. Ten of the seventy-three patients receiving irradiation have relapsed, all within 10 months after orchidectomy. The median time to relapse in both groups was 4.5 months. Irradiation prevented retroperitoneal relapses. Thirty-three of the relapsed patients were rendered disease free with chemotherapy, and one is still being treated. Four deaths have occurred, all unrelated to testicular cancer or antineoplastic treatment. Absence of embryonal carcinoma and presence of teratocarcinoma correlated with improved relapse-free survival. Patients with increased serum concentrations of tumour markers before orchidectomy had an increased risk of relapse. Surveillance-only is a reasonable treatment strategy in clinical stage I nonseminomatous testicular cancer. Preferably control and treatment of relapses should take place in specialized centres.