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ISRCTN
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ISRCTN18525328
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DOI
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10.1186/ISRCTN18525328
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A prospective comparison of two schedules of radiotherapy for stage I seminoma of the testis following orchidectomy
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Scientific title
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Acronym
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TE18
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Serial number at source
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TE18
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Local ethical committee approval was obtained from each participating centre.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stage I seminoma testis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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03/01/1995
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Anticipated end date
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03/01/1998
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600
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Interventions
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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.
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Primary outcome measure(s)
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Relapse-free rate, with relapse defined as the development of new masses (detected clinically or radiologically), or increasing tumor-specific markers (AFP, HCG).
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Secondary outcome measure(s)
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Impact of dose on acute morbidity and quality of life.
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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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
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Contact name
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Miss
Sharon
Naylor
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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28/02/2001
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Last edited
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20/12/2007
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Date ISRCTN assigned
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28/02/2001
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