Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sharon Naylor

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

  2. 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.

Additional files

Editorial Notes