Phase 3
N=75
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation
Cancer of the Cervix
Bottom Line
View on ClinicalTrials.gov: NCT01536392 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle — 49.8; 39.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Granisetron (Drug); Ondansetron (Drug); Questionnaires (Behavioral); Study Drug Diary (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle |
49.8; 39.7 | — |
| SECONDARY Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle |
49.8; 39.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women with cervical, endometrial or vaginal cancer dispositioned to receive primary or postoperative adjuvant pelvic radiation therapy with concurrent cisplatin administration.
- Women must be at least 18 years of age.
- Women must be able to read English or Spanish at a sixth grade level.
- Women with childbearing potential must have a negative pregnancy test within 1 week of starting chemoradiation therapy.
Exclusion Criteria
- Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy and/or radiation therapy for recurrent disease.
- Women with cervical, endometrial, or vaginal cancer who are receiving extended field radiation therapy.
- Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy and/or radiation therapy in a palliative setting.
- Women with cervical, endometrial, or vaginal cancer who have already received their first dose of chemotherapy or radiation for more than 7 days prior to starting chemotherapy.
Data sourced from ClinicalTrials.gov (NCT01536392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.