Overview

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

Status:
Completed
Trial end date:
2019-10-03
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Sancuso
Treatments:
Cisplatin
Granisetron
Ondansetron
Criteria
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.