Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TE18
Study information
Scientific title
Acronym
TE18
Study hypothesis
This trial was designed to compare the efficacy and the acute and long-term morbidity of standard radiotherapy with 30 Gy in 15 fractions versus 20 Gy in 10 fractions in patients with stage I seminoma testis.
Ethics approval
Local ethical committee approval was obtained from each participating centre.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Stage I seminoma testis
Intervention
1. One group receives 30 Gy, given in 15 daily (Monday through Friday) fractions of 2 Gy
2. The other group receives 20 Gy in 10 daily fractions of 2 Gy
Follow-up assessments will take place every three months in year one, every four months in year two, every six months in year three, and annually until year ten. Clinical examination and serum tumors markers will be required at each visit; chest x-rays are required at the six, 12-, 20-, 30-, and 36-month visits; and Computed Tomography (CT) scans of chest, abdomen, and pelvis are required at the 12-, 24-, and 36-month visits.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Relapse-free rate, with relapse defined as the development of new masses (detected clinically or radiologically), or increasing tumor-specific markers (AFP, HCG).
Secondary outcome measures
Impact of dose on acute morbidity and quality of life.
Overall trial start date
03/01/1995
Overall trial end date
03/01/1998
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically confirmed seminomatous germ cell tumour of the testis that is categorised as either 'Classical' or 'Anaplastic'
2. Stage I disease, based on clinical and radiologic examination, and normal postorchidectomy Alpha-FetoProtein (AFP) and Human Chorionic Gonadotropin (HCG)
3. All 'T' categories of primary tumour are eligible except those with involvement of the cut end of the spermatic cord
4. Patients with previous inguino-pelvic or scrotal surgery, have to be treated with 'dog-leg' fields
5. The interval between orchidectomy and randomisation should not exceed eight weeks. Treatment should start within two weeks thereafter
6. Consent to be randomised into the proposed study
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
600
Participant exclusion criteria
1. Increased serum alphafetoprotein (AFP) (but not human chorionic gonadotropin [HCG]) preorchidectomy
2. Coexistent or previously treated malignant disease or other condition or factor preventing adherence to the study schedule and follow-up
Recruitment start date
03/01/1995
Recruitment end date
03/01/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15718317
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16170196
Publication citations
-
Jones WG, Fossa SD, Mead GM, Roberts JT, Sokal M, Horwich A, Stenning SP, Randomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I Testicular Seminoma: a report on Medical Research Council Trial TE18, European Organisation for the Research and Treatment of Cancer Trial 30942 (ISRCTN18525328)., J. Clin. Oncol., 2005, 23, 6, 1200-1208, doi: 10.1200/JCO.2005.08.003.
-
Chan R, Randomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I testicular seminoma: a report on Medical Research Council Trial TE18, European Organisation for Research and Treatment of Cancer Trial 30942 (ISRCTN18525328)., J. Clin. Oncol., 2005, 23, 27, 6806; author reply 6806-7, doi: 10.1200/JCO.2005.01.8978.