In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

  • First Published: 7/1/1997
  • Last Modified: 3/14/2011

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

Phase III Randomized Study of Adjuvant Radiotherapy Versus Carboplatin in Patients With Stage I Testicular Seminoma. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed16 and overMRC-TE19
EORTC-30982, EU-97003, NCT00003014

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. 

Entry Criteria

Disease Characteristics:


Histologically confirmed stage I seminomatous germ cell tumor of the testis
categorized as either "classical" or "anaplastic" 
 

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 
   

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
 

Expected Enrollment

800

Approximately 800 patients will be accrued for this study within 4 years.

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.

Published Results

Oliver RT, Mason MD, Mead GM, et al.: Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial. Lancet 366 (9482): 293-300, 2005 Jul 23-29.[PUBMED Abstract]

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.

Oliver RT, Mead GM, Rustin GJ, et al.: 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 29 (8): 957-62, 2011.[PUBMED Abstract]

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.

Related Publications

Mead GM, Fossa SD, Oliver RT, et al.: Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst 103 (3): 241-9, 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Hans Von Der Maase, MD, Protocol chair
Ph: 45-8-949-2531
Email: maase@as.aaa.dk

Medical Research Council Clinical Trials Unit

R. T. Oliver, MD, Protocol chair
Ph: 44-207-601-8522
Email: r.t.oliver@qmul.ac.uk

Registry Information
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
Trial Start Date 1998-04-03
Registered in ClinicalTrials.gov NCT00003014
Date Submitted to PDQ 1997-01-01
Information Last Verified 2011-03-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Back to TopBack to Top