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NCT00003014

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

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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Testicular Germ Cell Tumor

Keywords

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stage I malignant testicular germ cell tumor testicular seminoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Principal Investigators

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Hans Von Der Maase, MD

Role: STUDY_CHAIR

Aarhus Universitetshospital - Aarhus Sygehus

R. T. Oliver, MD

Role: STUDY_CHAIR

St. Bartholomew's Hospital

Locations

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Porto Alegre Hospital

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

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Mount Sinai Hospital - Toronto

Toronto, Ontario, Canada

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Princess Margaret Hospital

Toronto, Ontario, Canada

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Hopital Sainte Justine

Montreal, Quebec, Canada

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Maria Hospital

Helsinki, , Finland

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Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

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Norwegian Radium Hospital

Oslo, , Norway

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Groote Schuur Hospital, Cape Town

Cape Town, , South Africa

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Royal United Hospital

Bath, England, United Kingdom

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University of Birmingham

Birmingham, England, United Kingdom

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Children's Hospital - Birmingham UK

Birmingham, England, United Kingdom

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Bradford Hospitals NHS Trust

Bradford, England, United Kingdom

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Royal Sussex County Hospital

Brighton, England, United Kingdom

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Bristol Royal Hospital for Sick Children

Bristol, England, United Kingdom

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

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Addenbrooke's NHS Trust

Cambridge, England, United Kingdom

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Kent and Canterbury Hospital

Canterbury, England, United Kingdom

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Walsgrave Hospital

Coventry, England, United Kingdom

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Derbyshire Royal Infirmary

Derby, England, United Kingdom

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Derbyshire Children's Hospital

Derby, England, United Kingdom

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Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

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Gloucester Royal NHS Trust - Glouchester Royal Hospital

Gloucester, England, United Kingdom

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Royal Surrey County Hospital

Guildford, England, United Kingdom

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Royal Free Hospital

Hampstead, London, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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Cookridge Hospital

Leeds, England, United Kingdom

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St. James's Hospital

Leeds, England, United Kingdom

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