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Home > "R" Clinical Trials Conditions > Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
For Condition: stage 1 testicular cancer,testicular seminoma
Status: No longer recruiting
Sponsor(s): Medical Research Council , EORTC Genito-Urinary Tract Cancer Cooperative Group
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry 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).
Total Enrollment:
Location and Contact Information:
Overall Study Official:
R.T.Oliver, Study Chair, Medical Research Council
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
United Kingdom
Royal Free Hospital
Hampstead, London, England, NW3 2QG
United Kingdom
Walsall Manor Hospital
Walsall, England, WS2 9PS
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Royal Infirmary
Glasgow, Scotland, G4 0SF
United Kingdom
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Guy's and St. Thomas' Hospitals Trust
London, England, SE1 7EH
United Kingdom
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland,
United Kingdom
Manchester Children's Hospitals (NHS Trust)
Manchester, England, M27 SHA
United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
United Kingdom
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD
United Kingdom
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
United Kingdom
South Tees Acute Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
United Kingdom
Derbyshire Children's Hospital
Derby, England, DE1 3BA
United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Maria Hospital
Helsinki, , FIN-0-0180
Finland
Bradford Hospitals NHS Trust
Bradford, England, BD9 6RJ
United Kingdom
Walsgrave Hospital
Coventry, England, CV2 2DX
United Kingdom
Royal South Hants Hospital
Southampton, England, SO14 0YG
United Kingdom
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Portsmouth Hospitals NHS Trust
Portsmouth, England, P03 6AD
United Kingdom
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, 90035--003
Brazil
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
United Kingdom
Royal Preston Hospital
Preston, , PR2 9HT
United Kingdom
University Hospitals of Leicester
Leicester, England, LE1 5WW
United Kingdom
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
United Kingdom
Cookridge Hospital
Leeds, England, LS16 6QB
United Kingdom
Royal Surrey County Hospital
Guildford, England, GU2 5XX
United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Westminster Hospital
London, England, SW1P 2AP
United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
United Kingdom
Llandough Hospital
Penarth, Wales, CF6 1XX
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
United Kingdom
Southend NHS Trust Hospital
Westcliff-On-Sea, England,
United Kingdom
Mount Vernon Hospital
Northwood, England, HA6 2RN
United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
United Kingdom
Royal Sussex County Hospital
Brighton, England, BN2 5BE
United Kingdom
Royal United Hospital
Bath, England, BA1 3NG
United Kingdom
University College Hospital
London, England, WC1E 6AU
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
St. Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
United Kingdom
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Saint Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Princess Royal Hospital
Telford, England, TF6 6TF
United Kingdom
Children's Hospital - Birmingham UK
Birmingham, England, B16 8ET
United Kingdom
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
Gloucester Royal NHS Trust - Glouchester Royal Hospital
Gloucester, England, GL1 3NN
United Kingdom
Bristol Royal Hospital for Sick Children
Bristol, England, BS2 8BJ
United Kingdom
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
United Kingdom
Groote Schuur Hospital, Cape Town
Cape Town, , 7925
South Africa
Additional Information:
Study ID Numbers: CDR0000065594; MRC-TE19,EU-97003
Study Start Date: April 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003014
Other Testicular Seminoma Studies:
1. Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
2. Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
Related Studies:
Other testicular seminoma Clinical Trials
Other England Clinical Trials
Other Derby Clinical Trials
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
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