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
|Phase III||Treatment||Closed||no age specified||MRC-TE10|
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.
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
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)
Age: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
400 patients will be entered.
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.
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
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.