Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
- Conditions
- Testicular Germ Cell Tumor
- Registration Number
- NCT00003014
- Lead Sponsor
- Medical Research Council
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Porto Alegre Hospital
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Norfolk & Norwich Hospital
🇬🇧Norwich, England, United Kingdom
Westminster Hospital
🇬🇧London, England, United Kingdom
Royal Free Hospital
🇬🇧Hampstead, London, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Llandough Hospital
🇬🇧Penarth, Wales, United Kingdom
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Groote Schuur Hospital, Cape Town
🇿🇦Cape Town, South Africa
Children's Hospital - Birmingham UK
🇬🇧Birmingham, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Derbyshire Children's Hospital
🇬🇧Derby, England, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Gloucester Royal NHS Trust - Glouchester Royal Hospital
🇬🇧Gloucester, England, United Kingdom
St. James's Hospital
🇬🇧Leeds, England, United Kingdom
South Tees Acute Hospitals NHS Trust
🇬🇧Middlesbrough, Cleveland, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University College Hospital
🇬🇧London, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Maria Hospital
🇫🇮Helsinki, Finland
University of Birmingham
🇬🇧Birmingham, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Princess Royal Hospital
🇬🇧Telford, England, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Bradford Hospitals NHS Trust
🇬🇧Bradford, England, United Kingdom
Bristol Royal Hospital for Sick Children
🇬🇧Bristol, England, United Kingdom
University Hospitals of Leicester
🇬🇧Leicester, 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
Walsall Manor Hospital
🇬🇧Walsall, England, United Kingdom
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Southend NHS Trust Hospital
🇬🇧Westcliff-On-Sea, England, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
🇬🇧Edinburgh, Scotland, United Kingdom
Manchester Children's Hospitals (NHS Trust)
🇬🇧Manchester, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Guy's and St. Thomas' Hospitals Trust
🇬🇧London, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom