Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
Recruitment status was Active, not recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 800 |
| Study Start Date: | April 1998 |
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 |
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
Hide Study Locations| Brazil | |
| 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 United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| University of Birmingham | |
| Birmingham, England, United Kingdom, B15 2TT | |
| Children's Hospital - Birmingham UK | |
| Birmingham, England, United Kingdom, B16 8ET | |
| Bradford Hospitals NHS Trust | |
| Bradford, England, United Kingdom, BD9 6RJ | |
| Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Bristol Royal Hospital for Sick Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Kent and Canterbury Hospital | |
| Canterbury, England, United Kingdom, CT2 7NR | |
| Walsgrave Hospital | |
| Coventry, England, United Kingdom, CV2 2DX | |
| Derbyshire Children's Hospital | |
| Derby, England, United Kingdom, DE1 3BA | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Royal Devon and Exeter Hospital | |
| Exeter, England, United Kingdom, EX2 5DW | |
| Gloucester Royal NHS Trust - Glouchester Royal Hospital | |
| Gloucester, England, United Kingdom, GL1 3NN | |
| Royal Surrey County Hospital | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Royal Free Hospital | |
| Hampstead, London, England, United Kingdom, NW3 2QG | |
| Huddersfield Royal Infirmary | |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, WIT 3AA | |
| Westminster Hospital | |
| London, England, United Kingdom, SW1P 2AP | |
| St. Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Guy's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 7EH | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| University College Hospital | |
| London, England, United Kingdom, WC1E 6AU | |
| Manchester Children's Hospitals (NHS Trust) | |
| Manchester, England, United Kingdom, M27 SHA | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| South Tees Acute Hospitals NHS Trust | |
| Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
| 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 | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Norfolk & Norwich Hospital | |
| Norwich, England, United Kingdom, NR1 3SR | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Portsmouth Hospitals NHS Trust | |
| Portsmouth, England, United Kingdom, P03 6AD | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Princess Royal Hospital | |
| Telford, England, United Kingdom, TF6 6TF | |
| Walsall Manor Hospital | |
| Walsall, England, United Kingdom, WS2 9PS | |
| Southend NHS Trust Hospital | |
| Westcliff-On-Sea, England, United Kingdom | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Royal Infirmary | |
| Glasgow, Scotland, United Kingdom, G4 0SF | |
| Ysbyty Gwynedd | |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Llandough Hospital | |
| Penarth, Wales, United Kingdom, CF6 1XX | |
| Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
| 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:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003014 History of Changes |
| Other Study ID Numbers: | CDR0000065594, MRC-TE19, EORTC-30982, EU-97003 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 15, 2011 |
| 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:
|
Seminoma Testicular Neoplasms Neoplasms, Germ Cell and Embryonal Germinoma Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Endocrine System Diseases Testicular Diseases Gonadal Disorders Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013