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 |
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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
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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 |
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 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 |
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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 |
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
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
| Study Chair: | David P. Dearnaley, MD, FRCP, FRCR | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00004219 History of Changes |
| 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):
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nausea and vomiting stage I malignant testicular germ cell tumor testicular seminoma |
Additional relevant MeSH terms:
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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 |