Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer

Testicular Germ Cell Tumor Clinical Trial

Official title:

Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy

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
• 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

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

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