TE04
A prospective study of surveillance in stage 1 non-seminomatous testicular tumours
Finding the best way to treat men with early testis cancer
What was this study about?
This was a prospective study, looking at men who were diagnosed with a type of testis cancer called stage I nonseminomatous germ cell testicular tumour (NSGCT) and who then had an operation to remove one or both testicles (orchidectomy). This was the largest study of its kind to date. Before the TE04 study, most men would receive additional treatment after their surgery to help prevent the cancer returning. We wanted to see if having regular hospital check ups after surgery alone (called surveillance) was a good way to treat these men, and also to look at whether detailed information about their tumour could be used to predict whether or not the cancer would return.
What difference did this study make?
The study found that surveillance was a good way to care for this group of men. Cancer came back in about one quarter of men, but in nearly all cases it was cured with further treatment and 5 years after surgery 98% of men were still alive. By looking at when the cancer came back, researchers were able to suggest that doctors should see these men frequently for two years after their operation, and continue to see them less frequently for a further three years.
This study also identified a smaller group of men, who were at greater risk of the cancer coming back. They therefore designed a study to test whether two courses of platinum-based chemotherapy after surgery would prevent the cancer coming back in these high-risk patients.
As a result of this study, surveillance became standard treatment for many patients with early testis cancer meaning that the majority could be cured by surgery alone. It also became possible to tell men what the chance of their cancer coming back would be if they had surveillance only after surgery. This meant that men were better informed, and those with a high risk of cancer returning could choose to have additional treatment to help prevent this if they wished.
Type of study
Randomised trial
Contact details
Who funded the study?
The Medical Research Council.
When did it take place?
Patients were recruited between January 1984 and October 1987.
Who was included?
396 men with NSGCT were recruited from 16 centres in the UK and one in Norway.