CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 76 enrolled
Drug / intervention
Granisetron +3 moredrug
Likely dose
Granisetron 34.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01536392
NCT01536392Phase 3Completed

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation

M.D. Anderson Cancer Center·interventional·Posted Feb 22, 2012·Updated Jun 11, 2021

In Brief

A Phase 3 clinical trial evaluating Granisetron, Ondansetron, and 2 other interventions for Cancer of the Cervix. Completed, enrolled 76 participants across 2 sites.

Detailed Summary

The goal of this clinical research study is to compare granisetron (when given through a patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with cervical, endometrial, or vaginal cancer having chemoradiation. Granisetron and ondansetron are designed to help reduce nausea and vomiting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSancuso

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartMar 1, 2012
Primary CompletionOct 3, 2019
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 14.4 years ago

Interventions

Granisetrondrug

34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch.

Ondansetrondrug

8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.

Questionnairesbehavioral

Completion of 3 questionnaires at study visits taking about 5 minutes each time.

Study Drug Diarybehavioral

Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.