Phase III Randomized Adjuvant Study of Two Schedules of Radiotherapy for Stage I Seminomatous Testicular Cancer Following Orchiectomy
Radiation Therapy in Treating Patients With Stage I Testicular Cancer
Basic Trial Information
|Phase III||Treatment||Closed||any age||MRC-TE18|
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.
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
No more than 8 weeks between orchiectomy and randomization Prior inguinopelvic or scrotal surgery, including vasectomy, allowed
Any age No prior or concomitant malignancy except treated nonmelanomatous skin cancer No medical condition or other factor that precludes study participation
It is anticipated that 600 patients will be entered over 3 years.
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.
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.
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
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.