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

December 3, 2013 updated by: Medical Research Council

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: R. T. Oliver, MD, St. Bartholomew's Hospital
  • Study Chair: Hans Von Der Maase, MD, Aarhus Universitetshospital - Aarhus Sygehus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 11, 2004

First Posted (ESTIMATE)

March 12, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065594
  • MRC-TE19
  • EORTC-30982
  • EU-97003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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