Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation
Cancer of the Cervix
About this trial
This is an interventional treatment trial for Cancer of the Cervix focused on measuring Cancer of the Cervix, Anti-emetic therapy, Granisetron, Transdermal patch, Ondansetron, Zofran, Questionnaires, Surveys, Study Drug Diary, 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.
Sites / Locations
- Lyndon B. Johnson General Hospital
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Granisetron
Ondansetron
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.
Group B: 8 mg of ondansetron orally thrice daily starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.