Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Objectives

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.

Entry Criteria

Disease Characteristics:

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

Prior/Concurrent Therapy:

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

Patient Characteristics:

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

Expected Enrollment

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.

Outline

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.

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 Contact Information

Trial Lead Organizations

Southwest Oncology Group

Thomas Stanisic, MD, Protocol chair		Ph: 309-673-7349

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