Clinical trial · Interventional
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation
NCT01536392CI-TRIAL-00052224completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granisetron | Drug | — | UNRESOLVED |
| Ondansetron | Drug | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Study Drug Diary | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Granisetron
- description
- Group A: 34.3 mg of granisetron formulated in transdermal patch replaced every 7 days. Transdermal patch placed/replaced prior to the intravenous (IV) infusion of cisplatin. At cycle 1, participants receive IV granisetron prior to IV cisplatin and prior to administration of transdermal patch.
- interventionNames
- Drug: Granisetron
- Behavioral: Questionnaires
- Behavioral: Study Drug Diary
- type
- EXPERIMENTAL
- label
- Ondansetron
- description
- Group B: 8 mg of ondansetron orally thrice daily starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.
- interventionNames
- Drug: Ondansetron
- Behavioral: Questionnaires
- Behavioral: Study Drug Diary
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with cervical, endometrial or vaginal cancer dispositioned to receive primary or postoperative adjuvant pelvic radiation therapy with concurrent cisplatin administration. 2. Women must be at least 18 years of age. 3. Women must be able to read English or Spanish at a sixth grade level. 4. Women with childbearing potential must have a negative pregnancy test within 1 week of starting chemoradiation therapy. Exclusion Criteria: 1. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy and/or radiation therapy for recurrent disease. 2. Women with cervical, endometrial, or vaginal cancer who are receiving extended field radiation therapy. 3. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy and/or radiation therapy in a palliative setting. 4. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.