Back to resultsRadiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
Primary Purpose
Testicular Germ Cell Tumor
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Testicular Germ Cell Tumor focused on measuring stage I malignant testicular germ cell tumor, testicular seminoma
Eligibility 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
Sites / Locations
- Porto Alegre Hospital
- Cancer Care Ontario-London Regional Cancer Centre
- Mount Sinai Hospital - Toronto
- Princess Margaret Hospital
- Hopital Sainte Justine
- Maria Hospital
- Antoni van Leeuwenhoekhuis
- Norwegian Radium Hospital
- Groote Schuur Hospital, Cape Town
- Royal United Hospital
- University of Birmingham
- Children's Hospital - Birmingham UK
- Bradford Hospitals NHS Trust
- Royal Sussex County Hospital
- Bristol Royal Hospital for Sick Children
- Bristol Haematology and Oncology Centre
- Addenbrooke's NHS Trust
- Kent and Canterbury Hospital
- Walsgrave Hospital
- Derbyshire Royal Infirmary
- Derbyshire Children's Hospital
- Royal Devon and Exeter Hospital
- Gloucester Royal NHS Trust - Glouchester Royal Hospital
- Royal Surrey County Hospital
- Royal Free Hospital
- Huddersfield Royal Infirmary
- Cookridge Hospital
- St. James's Hospital
- University Hospitals of Leicester
- Saint Bartholomew's Hospital
- St. Bartholomew's Hospital
- Guy's and St. Thomas' Hospitals Trust
- Westminster Hospital
- University College Hospital
- Middlesex Hospital- Meyerstein Institute
- Manchester Children's Hospitals (NHS Trust)
- Clatterbridge Centre for Oncology NHS Trust
- South Tees Acute Hospitals NHS Trust
- Newcastle General Hospital
- Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital
- Mount Vernon Hospital
- Norfolk & Norwich Hospital
- Oxford Radcliffe Hospital
- Portsmouth Hospitals NHS Trust
- Children's Hospital - Sheffield
- Weston Park Hospital
- Royal South Hants Hospital
- Southampton General Hospital
- Royal Marsden Hospital
- Princess Royal Hospital
- Walsall Manor Hospital
- Southend NHS Trust Hospital
- Royal Belfast Hospital for Sick Children
- Aberdeen Royal Infirmary
- Ninewells Hospital and Medical School
- Western General Hospital
- Royal Hospital for Sick Children
- Beatson Oncology Centre
- Royal Infirmary
- Ysbyty Gwynedd
- Llandough Hospital
- Royal Preston Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00003014
First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
Medical Research Council
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00003014
Brief Title
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Research Council
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Germ Cell Tumor
Keywords
stage I malignant testicular germ cell tumor, testicular seminoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Von Der Maase, MD
Organizational Affiliation
Aarhus Universitetshospital - Aarhus Sygehus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
R. T. Oliver, MD
Organizational Affiliation
St. Bartholomew's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Porto Alegre Hospital
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035--003
Country
Brazil
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Mount Sinai Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Maria Hospital
City
Helsinki
ZIP/Postal Code
FIN-0-0180
Country
Finland
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Groote Schuur Hospital, Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
University of Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Children's Hospital - Birmingham UK
City
Birmingham
State/Province
England
ZIP/Postal Code
B16 8ET
Country
United Kingdom
Facility Name
Bradford Hospitals NHS Trust
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Sick Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT2 7NR
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Derbyshire Children's Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE1 3BA
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Gloucester Royal NHS Trust - Glouchester Royal Hospital
City
Gloucester
State/Province
England
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hampstead, London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's and St. Thomas' Hospitals Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Westminster Hospital
City
London
State/Province
England
ZIP/Postal Code
SW1P 2AP
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Middlesex Hospital- Meyerstein Institute
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Manchester Children's Hospitals (NHS Trust)
City
Manchester
State/Province
England
ZIP/Postal Code
M27 SHA
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
L63 4JY
Country
United Kingdom
Facility Name
South Tees Acute Hospitals NHS Trust
City
Middlesbrough, Cleveland
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Norfolk & Norwich Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR1 3SR
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
State/Province
England
ZIP/Postal Code
P03 6AD
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Telford
State/Province
England
ZIP/Postal Code
TF6 6TF
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Southend NHS Trust Hospital
City
Westcliff-On-Sea
State/Province
England
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 9NQ
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Llandough Hospital
City
Penarth
State/Province
Wales
ZIP/Postal Code
CF6 1XX
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21212385
Citation
Mead GM, Fossa SD, Oliver RT, Joffe JK, Huddart RA, Roberts JT, Pollock P, Gabe R, Stenning SP; MRC/EORTC seminoma trial collaborators. Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst. 2011 Feb 2;103(3):241-9. doi: 10.1093/jnci/djq525. Epub 2011 Jan 6.
Results Reference
background
PubMed Identifier
16039331
Citation
Oliver RT, Mason MD, Mead GM, von der Maase H, Rustin GJ, Joffe JK, de Wit R, Aass N, Graham JD, Coleman R, Kirk SJ, Stenning SP; MRC TE19 collaborators and the EORTC 30982 collaborators. Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial. Lancet. 2005 Jul 23-29;366(9482):293-300. doi: 10.1016/S0140-6736(05)66984-X.
Results Reference
result
Citation
Oliver RT, Mason M, Von der Masse H, et al.: A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982. [Abstract] J Clin Oncol 22 (Suppl 14): A-4517, 386, 2004.
Results Reference
result
PubMed Identifier
21282539
Citation
Oliver RT, Mead GM, Rustin GJ, Joffe JK, Aass N, Coleman R, Gabe R, Pollock P, Stenning SP. Randomized trial of carboplatin versus radiotherapy for stage I seminoma: mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214). J Clin Oncol. 2011 Mar 10;29(8):957-62. doi: 10.1200/JCO.2009.26.4655. Epub 2011 Jan 31.
Results Reference
result
Citation
Oliver RT, Mead GM, Fogarty PJ, et al.: Radiotherapy versus carboplatin for stage I seminoma: updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214). [Abstract] J Clin Oncol 26 (Suppl 15): A-1, 2008.
Results Reference
result
Learn more about this trial
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
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