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	Treatment or Intervention	Phase
stage I testicular cancer testicular seminoma	Drug: carboplatin	Phase III

Further Study Details: 

OBJECTIVES: I. Determine whether relapse rates are equivalent in patients with Stage I seminoma testis treated with either adjuvant radiotherapy or with single agent carboplatin. II. Document symptoms and aspects of quality of life before and after treatment, and to compare the acute and intermediate (1-2 year) side effects of treatment using a diary card and the EORTC QLQ-C33 questionnaire, together with a development testicular tumor questionnaire. III. Collect data on the incidence of late side effects of treatment (such as bowel dysfunction) and second malignancies.

PROTOCOL OUTLINE: This is a randomized study. One group of patients receives a single IV dose of carboplatin. The second group of patients receives radiotherapy daily for 5 days per week. Patients are followed every 3, 4, and 6 months for the first, second, and third year, respectively. Patients are followed annually thereafter.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued over 4 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed stage I seminomatous germ cell tumor of the testis categorized as either "Classical" or "Anaplastic"

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: No more than 8 weeks since orchidectomy

--Patient Characteristics--

• Age: Not specified
• Performance status: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Creatinine less than 1.4 mg/dL
• Other: No co-existent or previously treated malignant disease, except successfully treated nonmelanotic skin cancer; No medical condition or other factor preventing adherence to the study schedule and follow-up; Patients with previous inguino-pelvic or scrotal surgery are eligible, but have to be treated with "dog-leg" field if randomized to radiotherapy (in patients with vasectomy, the choice of fields is left up to the clinician).

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

Study chairs or principal investigators

R.T. Oliver,  Study Chair,  Medical Research Council   
Aldo V. Bono,  Study Chair

Study ID Numbers:  CDR0000065594; MRC-TE19; EU-97003
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003014
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08