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

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ClinicalTrials.gov Identifier: NCT00004219
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 9, 2004
Last Update Posted : August 2, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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.


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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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 the National Library of Medicine

Drug Information available for: Granisetron

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004219


Sponsors and Collaborators
Simbec Research
Investigators
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Study Chair: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
More Information
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ClinicalTrials.gov Identifier: NCT00004219    
Other Study ID Numbers: SIMBEC-RD526/21494
CDR0000067456 ( Registry Identifier: PDQ (Physician Data Query) )
EU-99027
First Posted: August 9, 2004    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: June 2007
Keywords provided by National Cancer Institute (NCI):
nausea and vomiting
stage I malignant testicular germ cell tumor
testicular seminoma
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Seminoma
Nausea
Vomiting
Signs and Symptoms, Digestive
Neoplasms by Histologic Type
Neoplasms
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