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NCT01536392 · ClinicalTrials.gov registry record · Phase 3
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 76
- Enrollment target
NCT01536392: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT01536392 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 76 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01536392, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 76 participants
- Enrollment target
Study 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.
Primary Outcome
Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of
Interventions
- BEHAVIORAL Questionnaires
- DRUG Ondansetron
- DRUG Granisetron
- BEHAVIORAL Study Drug Diary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2012-03 |
| Est. Completion | 2019-10-03 |
| Phase | Phase 3 |
What the finished NCT01536392 record still lists
NCT01536392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Questionnaires is the first listed.
NCT01536392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01536392 about?
NCT01536392 is a clinical study titled "Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation". 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...
What is the current status of trial NCT01536392?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 76 participants. The study started on 2012-03. Estimated completion is 2019-10-03.
What interventions are being tested in trial NCT01536392?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Ondansetron (DRUG), Granisetron (DRUG), Study Drug Diary (BEHAVIORAL).
Who is sponsoring clinical trial NCT01536392?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01536392's enrollment target sits among peer trials
76 1773rd of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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