A Phase III Study Assessing Chemoradiation Alone and with Additional Chemotherapy in Women with Locally Advanced, Inoperable Cervical Cancer: The OUTBACK Trial

Protocol
12-171
Full Title
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment For Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: THE OUTBACK TRIAL (GOG 274)
Phase
III
Purpose

Radiation therapy plus the chemotherapy drug cisplatin (“chemoradiation”) is the standard treatment for cervical cancer that has spread beyond the cervix. The purpose of this study is to see if adding the drugs carboplatin and paclitaxel after chemoradiation reduces the risk of cancer recurrence and improves patient survival.

Patients will be randomly assigned to receive chemoradiation alone, or chemoradiation plus carboplatin and paclitaxel. Researchers will compare the two groups with respect to cancer recurrence rate, survival, and quality of life.

This study is being conducted by the Gynecologic Oncology Group and the Radiation Therapy Oncology Group.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced cervical cancer that cannot be surgically removed.
  • Patients may not have had prior chemotherapy or radiation therapy for cervical cancer.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario Leitao at 212-639-3987.

Disease(s)
Cervical Cancer
Locations
Related Diseases