Know Cancer

or
forgot password

A Study to Investigate the Efficacy and Tolerability of Two Dose Levels of Lerisetron Compared With Granisetron in Patients Receiving Radiotherapy for Stage I Seminoma


Phase 3
18 Years
70 Years
Open (Enrolling)
Male
Nausea and Vomiting, Testicular Germ Cell Tumor

Thank you

Trial Information

A Study to Investigate the Efficacy and Tolerability of Two Dose Levels of Lerisetron Compared With Granisetron in Patients Receiving Radiotherapy for Stage I Seminoma


OBJECTIVES: I. Compare the efficacy and safety of lerisetron versus granisetron
hydrochloride in the prevention of radiotherapy induced nausea and vomiting in men with
stage I testicular seminoma.

OUTLINE: This is a randomized, double blind, parallel, multicenter study. Patients are
randomized to one of three treatment arms. Arm I: Patients receive oral lerisetron with an
oral placebo once daily for 14 days. Arm II: Patients receive oral lerisetron once daily for
14 days. Arm III: Patients receive oral granisetron hydrochloride once daily for 14 days. At
1-2 hours following antiemetics, all patients undergo concurrent daily radiotherapy for at
least 10 out of 14 days. Patients are followed daily for 10 days.

PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of stage I seminoma No clinical evidence of brain
metastases

PATIENT CHARACTERISTICS: Age: 18 to 70 Sex: Male Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: No significant hepatic
impairment Renal: No significant renal impairment Other: No known hypersensitivity to
serotonin antagonists No prior anticipatory emesis No communication impairments (e.g.,
language problem, poor mental development, or impaired cerebral function) that would
preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No concurrent corticosteroids except topical 1% hydrocortisone or
equivalent Radiotherapy: No prior radiotherapy Surgery: Not specified Other: At least 48
hours since prior antiemetics No other concurrent antiemetics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

David P. Dearnaley, MD, FRCP, FRCR

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000067456

NCT ID:

NCT00004219

Start Date:

Completion Date:

Related Keywords:

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

Name

Location