Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer - Full Text View

Sponsor:	Medical Research Council
Collaborator:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003014

Purpose

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.

Condition	Intervention	Phase
Testicular Germ Cell Tumor	Drug: carboplatin Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Testicular Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	800
Study Start Date:	April 1998

Detailed 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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003014

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Locations

Brazil, Rio Grande do Sul
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, Brazil, 90035--003
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Finland
Maria Hospital
Helsinki, Finland, FIN-0-0180
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
South Africa
Groote Schuur Hospital, Cape Town
Cape Town, South Africa, 7925
United Kingdom
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
United Kingdom, England
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom, CB2 2QQ
Bradford Hospitals NHS Trust
Bradford, England, United Kingdom, BD9 6RJ
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Bristol Royal Hospital for Sick Children
Bristol, England, United Kingdom, BS2 8BJ
Children's Hospital - Birmingham UK
Birmingham, England, United Kingdom, B16 8ET
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, L63 4JY
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Derbyshire Children's Hospital
Derby, England, United Kingdom, DE1 3BA
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Gloucester Royal NHS Trust - Glouchester Royal Hospital
Gloucester, England, United Kingdom, GL1 3NN
Guy's and St. Thomas' Hospitals Trust
London, England, United Kingdom, SE1 7EH
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
Manchester Children's Hospitals (NHS Trust)
Manchester, England, United Kingdom, M27 SHA
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Norfolk & Norwich Hospital
Norwich, England, United Kingdom, NR1 3SR
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Portsmouth Hospitals NHS Trust
Portsmouth, England, United Kingdom, P03 6AD
Princess Royal Hospital
Telford, England, United Kingdom, TF6 6TF
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Royal Free Hospital
Hampstead, London, England, United Kingdom, NW3 2QG
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Royal South Hants Hospital
Southampton, England, United Kingdom, SO14 0YG
Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 5XX
Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
University College Hospital
London, England, United Kingdom, WC1E 6AU
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
South Tees Acute Hospitals NHS Trust
Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom
St. Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
University Hospitals of Leicester
Leicester, England, United Kingdom, LE1 5WW
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
Walsall Manor Hospital
Walsall, England, United Kingdom, WS2 9PS
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Westminster Hospital
London, England, United Kingdom, SW1P 2AP
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
United Kingdom, Wales
Llandough Hospital
Penarth, Wales, United Kingdom, CF6 1XX
Ysbyty Gwynedd
Bangor, Wales, United Kingdom, LL57 2PW

Sponsors and Collaborators

Medical Research Council

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:	Hans Von Der Maase, MD	Aarhus Universitetshospital - Aarhus Sygehus
Study Chair:	R. T. Oliver, MD	St. Bartholomew's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 of stage I seminoma: a randomised trial. Lancet. 2005 Jul 23-29;366(9482):293-300.

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 14): A-4517, 386, 2004.

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.

Study ID Numbers:	CDR0000065594, MRC-TE19, EORTC-30982, EU-97003
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003014 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I malignant testicular germ cell tumor
testicular seminoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Germ Cell and Embryonal
Carboplatin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009