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Clinical Trials (PDQ®)

  • Last Modified: 3/14/2011

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Clinical Trials (PDQ®)

Phase III Prospective Randomized Study of Adjuvant Radiotherapy to the Para-Aortic Nodes vs the Para-Aortic and Ipsilateral External Iliac Nodes Following Orchiectomy in Patients with Stage I Seminoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedno age specifiedMRC-TE10
EU-90019

Objectives

I.  Compare the relapse rate and sites of relapse in patients receiving 
adjuvant radiotherapy to the para-aortic nodes alone vs. the para-aortic and 
ipsilateral external iliac nodes following orchiectomy for Stage I seminoma.
II.  Compare the acute side effects of treatment.
III.  Compare side effects up to 2 years after treatment.
IV.  Determine the efficacy of local-field pelvic node irradiation to treat 
recurrence in patients originally treated with para-aortic fields alone.

Entry Criteria

Disease Characteristics:


Histologically confirmed, Stage I seminomatous germ cell
tumor of the testis that is anaplastic or classical

Stage I disease defined as follows:
  No clinical evidence of metastatic disease
  Normal chest x-ray
  Normal abdominal lymphogram or abdominal/pelvic CT scan
  Normal AFP and HCG (elevated HCG prior to orchiectomy
  allowed)
  Any T except T4 (involvement of spermatic cord)

  Seminoma/teratoma and spermatocytic seminoma excluded


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  Not specified

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  No more than 6 weeks between orchiectomy and entry
  No prior ipsilateral inguinal operations
     (herniorrhaphy, orchiopexy)


Patient Characteristics:


Age:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified


Expected Enrollment

400 patients will be entered.

Outline

Randomized study.
Arm I:  Radiotherapy.  Irradiation of para-aortic nodes using linear 
accelerators.
Arm II:  Radiotherapy.  Irradiation of para-aortic and ipsilateral iliac 
pelvic nodes using linear accelerators.

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

Medical Research Council Clinical Trials Unit

Alan Horwich, MD, PhD, FRCP, FRCR, Protocol chair
Ph: 44-20-8661-3274

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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