Study:
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial
Rationale:
Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. External radiation therapy uses high-energy x rays to kill
tumor cells. Internal radiation uses radioactive material placed directly into or near a
tumor to kill tumor cells. It is not yet know whether giving cisplatin and external and
internal radiation therapy together with carboplatin and paclitaxel kill more tumor cells.
Purpose:
This randomized phase III trial studies how well giving cisplatin and radiation
therapy together with or without carboplatin and paclitaxel works in treating patients with
locally advanced cervical cancer.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Cancer Center at Fai 216-476-9362
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
Cervical Cancer
Chemotherapeutic Agent Toxicity
Cognitive/Functional Effects
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexuality and Reproductive Issues |
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel |
Phase 3 |
Verified by
Gynecologic Oncology Group
October, 2012
Sponsored by: Gynecologic Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT01414608
Study Type: Interventional
Study Design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Kathleen N. Moore, MD., Principal Investigator