A prospective comparison of two schedules of radiotherapy for stage I seminoma of the testis following orchidectomy
| ISRCTN | ISRCTN18525328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18525328 |
| Secondary identifying numbers | TE18 |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 20/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Sharon Naylor
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TE18 |
| Study objectives | 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(s) | Local ethical committee approval was obtained from each participating centre. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 03/01/1995 |
| Completion date | 03/01/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 600 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/01/1995 |
| Date of final enrolment | 03/01/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/02/2005 | Yes | No | ||
| Other publications | 20/09/2005 | Yes | No |
