Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea and Vomiting; Testicular Germ Cell Tumor
Intervention: granisetron hydrochloride (Drug); lerisetron (Drug); radiation therapy (Radiation)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Simbec Research Official(s) and/or principal investigator(s): David P. Dearnaley, MD, FRCP, FRCR, Study Chair, Affiliation: Royal Marsden NHS Foundation Trust
Summary
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients
treated with radiation therapy. It is not yet known whether lerisetron is more effective
than granisetron in preventing nausea and vomiting.
PURPOSE: Randomized phase III trial to compare the effectiveness of lerisetron with that of
granisetron in preventing nausea and vomiting in men who are being treated with radiation
therapy for stage I seminoma.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Primary Purpose: Supportive Care
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Male.
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
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Additional Information
Last updated: August 1, 2013
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