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Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy


Phase 3
16 Years
N/A
Open (Enrolling)
Male
Testicular Germ Cell Tumor

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Trial Information

Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy


OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated
with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before
and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year)
side effects of these regimens in these patients. IV. Determine the incidence of late side
effects (such as bowel dysfunction) of treatment and second malignancies in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm
I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy
once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months
for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage I seminomatous germ cell tumor of
the testis categorized as either "classical" or "anaplastic"

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Hematopoietic:
Not specified Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Other: No
concurrent or previously treated malignancy except successfully treated nonmelanoma skin
cancer No medical condition or other factor that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No more than 8 weeks
since prior orchidectomy Prior inguino-pelvic or scrotal surgery allowed Must be treated
with "dog-leg" field if randomized to radiotherapy If prior vasectomy, choice of fields is
at the discretion of the clinician

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Hans Von Der Maase, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Aarhus Universitetshospital - Aarhus Sygehus

Authority:

United States: Federal Government

Study ID:

CDR0000065594

NCT ID:

NCT00003014

Start Date:

April 1998

Completion Date:

Related Keywords:

  • Testicular Germ Cell Tumor
  • stage I malignant testicular germ cell tumor
  • testicular seminoma
  • Seminoma
  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal

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