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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003014
Other study ID # CDR0000065594
Secondary ID MRC-TE19EORTC-30
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated December 3, 2013
Start date April 1998
Est. completion date July 2005

Study information

Verified date March 2011
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.


Description:

OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year) side effects of these regimens in these patients. IV. Determine the incidence of late side effects (such as bowel dysfunction) of treatment and second malignancies in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 16 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically confirmed stage I seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic"

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Other: No concurrent or previously treated malignancy except successfully treated nonmelanoma skin cancer No medical condition or other factor that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No more than 8 weeks since prior orchidectomy Prior inguino-pelvic or scrotal surgery allowed Must be treated with "dog-leg" field if randomized to radiotherapy If prior vasectomy, choice of fields is at the discretion of the clinician

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
carboplatin

Radiation:
radiation therapy


Locations

Country Name City State
Brazil Porto Alegre Hospital Porto Alegre Rio Grande do Sul
Canada Cancer Care Ontario-London Regional Cancer Centre London Ontario
Canada Hopital Sainte Justine Montreal Quebec
Canada Mount Sinai Hospital - Toronto Toronto Ontario
Canada Princess Margaret Hospital Toronto Ontario
Finland Maria Hospital Helsinki
Netherlands Antoni van Leeuwenhoekhuis Amsterdam
Norway Norwegian Radium Hospital Oslo
South Africa Groote Schuur Hospital, Cape Town Cape Town
United Kingdom Aberdeen Royal Infirmary Aberdeen Scotland
United Kingdom Ysbyty Gwynedd Bangor Wales
United Kingdom Royal United Hospital Bath England
United Kingdom Royal Belfast Hospital for Sick Children Belfast Northern Ireland
United Kingdom Children's Hospital - Birmingham UK Birmingham England
United Kingdom University of Birmingham Birmingham England
United Kingdom Bradford Hospitals NHS Trust Bradford England
United Kingdom Royal Sussex County Hospital Brighton England
United Kingdom Bristol Haematology and Oncology Centre Bristol England
United Kingdom Bristol Royal Hospital for Sick Children Bristol England
United Kingdom Addenbrooke's NHS Trust Cambridge England
United Kingdom Kent and Canterbury Hospital Canterbury England
United Kingdom Walsgrave Hospital Coventry England
United Kingdom Derbyshire Children's Hospital Derby England
United Kingdom Derbyshire Royal Infirmary Derby England
United Kingdom Ninewells Hospital and Medical School Dundee Scotland
United Kingdom Royal Hospital for Sick Children Edinburgh Scotland
United Kingdom Western General Hospital Edinburgh Scotland
United Kingdom Royal Devon and Exeter Hospital Exeter England
United Kingdom Beatson Oncology Centre Glasgow Scotland
United Kingdom Royal Infirmary Glasgow Scotland
United Kingdom Gloucester Royal NHS Trust - Glouchester Royal Hospital Gloucester England
United Kingdom Royal Surrey County Hospital Guildford England
United Kingdom Royal Free Hospital Hampstead, London England
United Kingdom Huddersfield Royal Infirmary Huddersfield, West Yorks England
United Kingdom Cookridge Hospital Leeds England
United Kingdom St. James's Hospital Leeds England
United Kingdom University Hospitals of Leicester Leicester England
United Kingdom Guy's and St. Thomas' Hospitals Trust London England
United Kingdom Middlesex Hospital- Meyerstein Institute London England
United Kingdom Saint Bartholomew's Hospital London England
United Kingdom St. Bartholomew's Hospital London England
United Kingdom University College Hospital London England
United Kingdom Westminster Hospital London England
United Kingdom Manchester Children's Hospitals (NHS Trust) Manchester England
United Kingdom Clatterbridge Centre for Oncology NHS Trust Merseyside England
United Kingdom South Tees Acute Hospitals NHS Trust Middlesbrough, Cleveland England
United Kingdom Newcastle General Hospital Newcastle Upon Tyne England
United Kingdom Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital Newcastle-Upon-Tyne England
United Kingdom Mount Vernon Hospital Northwood England
United Kingdom Norfolk & Norwich Hospital Norwich England
United Kingdom Oxford Radcliffe Hospital Oxford England
United Kingdom Llandough Hospital Penarth Wales
United Kingdom Portsmouth Hospitals NHS Trust Portsmouth England
United Kingdom Royal Preston Hospital Preston
United Kingdom Children's Hospital - Sheffield Sheffield England
United Kingdom Weston Park Hospital Sheffield England
United Kingdom Royal South Hants Hospital Southampton England
United Kingdom Southampton General Hospital Southampton England
United Kingdom Royal Marsden Hospital Sutton England
United Kingdom Princess Royal Hospital Telford England
United Kingdom Walsall Manor Hospital Walsall England
United Kingdom Southend NHS Trust Hospital Westcliff-On-Sea England

Sponsors (2)

Lead Sponsor Collaborator
Medical Research Council European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Brazil,  Canada,  Finland,  Netherlands,  Norway,  South Africa,  United Kingdom, 

References & Publications (5)

Mead GM, Fossa SD, Oliver RT, Joffe JK, Huddart RA, Roberts JT, Pollock P, Gabe R, Stenning SP; MRC/EORTC seminoma trial collaborators. Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst. 2011 Feb 2;103(3):241-9. doi: 10.1093/jnci/djq525. Epub 2011 Jan 6. — View Citation

Oliver RT, Mason M, Von der Masse H, et al.: A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982. [Abstract] J Clin Oncol 22 (Suppl

Oliver RT, Mason MD, Mead GM, von der Maase H, Rustin GJ, Joffe JK, de Wit R, Aass N, Graham JD, Coleman R, Kirk SJ, Stenning SP; MRC TE19 collaborators and the EORTC 30982 collaborators. Radiotherapy versus single-dose carboplatin in adjuvant treatment o — View Citation

Oliver RT, Mead GM, Fogarty PJ, et al.: Radiotherapy versus carboplatin for stage I seminoma: updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214). [Abstract] J Clin Oncol 26 (Suppl 15): A-1, 2008.

Oliver RT, Mead GM, Rustin GJ, Joffe JK, Aass N, Coleman R, Gabe R, Pollock P, Stenning SP. Randomized trial of carboplatin versus radiotherapy for stage I seminoma: mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 s — View Citation

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