Clinical Trials (PDQ®)
|No phase specified||Supportive care||Closed||any age||NCI||SWOG-8711|
I. Evaluate the natural history of seminal fluid and hormonal parameters noted in Stage A testicular cancer patients treated by orchiectomy alone. II. Evaluate the effects of a) orchiectomy plus platinum-based combination chemotherapy or radiotherapy and b) retroperitoneal node dissection on the seminal fluid and hormonal parameters of Stage B or C testicular cancer patients. III. Estimate the median time to return of ejaculatory function following orchiectomy and retroperitoneal node dissection. IV. Study the effect of testicular cancer on sexual/reproductive function.
Histologically diagnosed testicular cancer that has undergone orchiectomy within 12 weeks prior to entry and meeting the criteria for one of the following groups: Group I: Stage A (tumor confined to the testis) with no planned retroperitoneal lymphadenectomy (RPLND) Group II: Stage A Stage B1 (involvement of fewer than 6 positive retroperitoneal lymph nodes) Stage B2 (involvement of more than 6 positive nodes) Stage B3 (massive involvement of nodes) Stage C (tumor metastatic to nodes above the diaphragm or to distant sites) with no planned RPLND that is to undergo either of the following: Chemotherapy without radiotherapy for nonseminomatous tumors or seminoma (prior or concomitant radiotherapy is not allowed) Radiotherapy alone for seminoma Group III: Stage A, B, or C, that, after orchiectomy alone, is to undergo one of the following: RPLND alone RPLND plus chemotherapy RPLND plus radiotherapy No cryptorchid patients
Biologic therapy: Not specified Chemotherapy: No chemotherapy prior to the diagnosis of testis cancer Chemotherapy following orchiectomy and prior to registration allowed Endocrine therapy: Orchiectomy within 12 weeks prior to entry required Radiotherapy: No radiotherapy prior to the diagnosis of testis cancer Radiotherapy following orchiectomy and prior to registration allowed Surgery: No RPLND prior to the diagnosis of testis cancer RPLND following orchiectomy and prior to registration allowed
Age: Any age Performance status: SWOG 0-2 Life expectancy: At least 1 year Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of sterilization or abnormal sexual development (i.e., hypogonadism) Prestudy laboratory values should be obtained as close to the time of orchiectomy as possible and prior to registration
A total of 300 patients (50 per group or subset) will be studied; at a estimated accrual rate of 12 patients per month, 25 months will be required for completion of accrual.
Nonrandomized study. Evaluation of Reproductive Function. Analysis of sexual and hormonal parameters following orchiectomy with or without subsequent lymphadenectomy, chemotherapy, or radiotherapy in the treatment of testicular cancer.Published Results
Gordon W Jr, Siegmund K, Stanisic TH, et al.: A study of reproductive function in patients with seminoma treated with radiotherapy and orchidectomy: (SWOG-8711). Southwest Oncology Group. Int J Radiat Oncol Biol Phys 38 (1): 83-94, 1997.[PUBMED Abstract]
Trial Lead Organizations
Southwest Oncology Group
|Thomas Stanisic, MD, Protocol chair|
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.