Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00004219

First received: January 28, 2000

Last updated: August 1, 2013

Last verified: June 2007

History of Changes

Purpose

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.

Condition	Intervention	Phase
Nausea and Vomiting Testicular Germ Cell Tumor	Drug: granisetron hydrochloride Drug: lerisetron Radiation: radiation therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Granisetron hydrochloride Granisetron

Genetic and Rare Diseases Information Center resources: Testicular Cancer Testicular Seminoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Estimated Enrollment:	150

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


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004219

Sponsors and Collaborators

Simbec Research

Investigators


Study Chair:	David P. Dearnaley, MD, FRCP, FRCR	Royal Marsden NHS Foundation Trust

More Information


ClinicalTrials.gov Identifier:	NCT00004219 History of Changes
Other Study ID Numbers:	SIMBEC-RD526/21494 CDR0000067456 ( Registry Identifier: PDQ (Physician Data Query) ) EU-99027
Study First Received:	January 28, 2000
Last Updated:	August 1, 2013

Keywords provided by National Cancer Institute (NCI):


nausea and vomiting stage I malignant testicular germ cell tumor testicular seminoma

Additional relevant MeSH terms:


Nausea Vomiting Neoplasms, Germ Cell and Embryonal Testicular Neoplasms Seminoma Signs and Symptoms, Digestive Signs and Symptoms Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male	Endocrine System Diseases Testicular Diseases Gonadal Disorders Germinoma Granisetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017

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