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Clinical Trials (PDQ®)

Phase III Randomized Adjuvant Study of Two Schedules of Radiotherapy for Stage I Seminomatous Testicular Cancer Following Orchiectomy

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

Alternate Title

Radiation Therapy in Treating Patients With Stage I Testicular Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageMRC-TE18
EU-95033

Objectives

I.  Compare relapse rates in patients with Stage I seminomatous testicular 
cancer after treatment with 30 vs. 20 Gy (2 Gy/day fraction) of adjuvant 
radiotherapy following orchiectomy.

II.  Compare the acute and intermediate (1-2 years after treatment) toxicities 
in these patients by documenting symptoms and aspects of quality of life pre- 
and post-radiotherapy using a patient diary card and EORTC QLQ-C33 
supplemented by the Testicular Tumor Questionnaire.

III.  Collect data on the late side effects of treatment (e.g., bowel 
dysfunction) and second malignancies, the latter in parallel with an ongoing 
retrospective study of second malignancies in such patients.

Entry Criteria

Disease Characteristics:


Histologically confirmed seminomatous germ cell tumor of the testis that is
anaplastic or classical
  No combined teratoma/seminoma or spermatocytic seminoma

Stage I disease, defined as follows:
  Normal chest x-ray
  Normal chest and abdominopelvic CT
  Normal alpha-fetoprotein and human chorionic gonadotropin (HCG)
     (elevated HCG prior to orchiectomy allowed)
  Pathologic T1-3 if no involvement of cut end of spermatic cord
  No clinical evidence of metastatic disease


Prior/Concurrent Therapy:


No more than 8 weeks between orchiectomy and randomization

Prior inguinopelvic or scrotal surgery, including vasectomy, allowed


Patient Characteristics:


Any age

No prior or concomitant malignancy except treated nonmelanomatous skin cancer

No medical condition or other factor that precludes study participation


Expected Enrollment

It is anticipated that 600 patients will be entered over 3 years.

Outline

Randomized study.

Arm I:  Radiotherapy.  External-beam irradiation of the para-aortic nodes 
using a linear accelerator.  15-fraction schedule over 3 weeks.

Arm II:  Radiotherapy.  As in Arm I.  10-fraction schedule over 2 weeks.

Published Results

Jones WG, Fossa SD, Mead GM, et al.: Randomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I Testicular Seminoma: a report on Medical Research Council Trial TE18, European Organisation for the Research and Treatment of Cancer Trial 30942 (ISRCTN18525328). J Clin Oncol 23 (6): 1200-8, 2005.[PUBMED Abstract]

Jones WG, Fossa SD, Mead GM, et al.: A randomised trial of two radiotherapy schedules in the adjuvant treatment of stage I seminoma (MRC TE18). [Abstract] Eur J Cancer 37 (suppl 6): A-572, s157, 2001.

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]

Chan R: Randomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I testicular seminoma: a report on Medical Research Council Trial TE18, European Organisation for Research and Treatment of Cancer Trial 30942 (ISRCTN18525328). J Clin Oncol 23 (27): 6806; author reply 6806-7, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

William George Jones, MD, ChB, FRCR, Protocol chair
Ph: 44-113-392-4227

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.

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