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

NCT00003014 | Completed Phase 3

• 4 other identifiers: CDR0000065594MRC-TE19EORTC-30982EU-97003
• Study Type: interventional
• Target: 800
• Locations: 7 countries
• Sites: 62

Brief 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.

Conditions

Testicular Germ Cell Tumor

Keywords

stage I malignant testicular germ cell tumor; testicular seminoma

Interventions

carboplatin DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (62)

Porto Alegre Hospital

Porto Alegre, Rio Grande do Sul, 90035--003, Brazil

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Maria Hospital

Helsinki, FIN-0-0180, Finland

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Groote Schuur Hospital, Cape Town

Cape Town, 7925, South Africa

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

University of Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Children's Hospital - Birmingham UK

Birmingham, England, B16 8ET, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, England, BD9 6RJ, United Kingdom

Location

Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Bristol Royal Hospital for Sick Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Derbyshire Children's Hospital

Derby, England, DE1 3BA, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Gloucester Royal NHS Trust - Glouchester Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, England, GU2 5XX, United Kingdom

Location

Royal Free Hospital

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

University Hospitals of Leicester

Leicester, England, LE1 5WW, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Guy's and St. Thomas' Hospitals Trust

London, England, SE1 7EH, United Kingdom

Location

Westminster Hospital

London, England, SW1P 2AP, United Kingdom

Location

University College Hospital

London, England, WC1E 6AU, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Manchester Children's Hospitals (NHS Trust)

Manchester, England, M27 SHA, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, L63 4JY, United Kingdom

Location

South Tees Acute Hospitals NHS Trust

Middlesbrough, Cleveland, England, TS4 3BW, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk & Norwich Hospital

Norwich, England, NR1 3SR, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, England, P03 6AD, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Princess Royal Hospital

Telford, England, TF6 6TF, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Llandough Hospital

Penarth, Wales, CF6 1XX, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Related 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.

  PMID: 21212385 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)66984-X.

  PMID: 16039331 RESULT

• 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.

  RESULT

• 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 study (ISRCTN27163214). J Clin Oncol. 2011 Mar 10;29(8):957-62. doi: 10.1200/JCO.2009.26.4655. Epub 2011 Jan 31.

  PMID: 21282539 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Testicular Germ Cell Tumor; Testicular Neoplasms; Seminoma

Interventions

Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• Hans Von Der Maase, MD

  Aarhus Universitetshospital - Aarhus Sygehus

  STUDY CHAIR

• R. T. Oliver, MD

  St. Bartholomew's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 12, 2004
• Study Start: April 1, 1998
• Study Completion: July 1, 2005
• Last Updated: December 4, 2013

Record last verified: 2011-03

Locations

BR (1); GB (53); CA (4); FI (1); NL (1); NO (1); ZA (1)