NCT00004219

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 9, 2004

Completed
Last Updated

August 2, 2013

Status Verified

June 1, 2007

First QC Date

January 28, 2000

Last Update Submit

August 1, 2013

Conditions

Nausea and VomitingTesticular Germ Cell Tumor

Keywords

nausea and vomitingstage I malignant testicular germ cell tumortesticular seminoma

Interventions

granisetron hydrochlorideDRUG
lerisetronDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

NauseaVomitingTesticular Germ Cell TumorTesticular NeoplasmsSeminoma

Interventions

GranisetronlerisetronRadiotherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersGerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTherapeutics

Study Officials

  • David P. Dearnaley, MD, FRCP, FRCR

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 28, 2000

First Posted

August 9, 2004

Last Updated

August 2, 2013

Record last verified: 2007-06