A phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone: THE OUTBACK TRIAL
Study Status
Open to Enrollment
Study Description
This clinical trial is for women with locally advanced cervical cancer. The study will evaluate how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer.
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.
The purpose of this study is to compare standard treatment--radiation therapy combined with the chemotherapy drug cisplatin (chemo-radiation)-- to standard chemo-radiation therapy plus additional experimental chemotherapy with FDA approved agents carboplatin and paclitaxel to see if it reduces the risk of tumor recurrence and improves overall survival.
In the study one group will receive standard chemo-radiation alone, and another group will receive standard chemo-radiation and then additional chemotherapy. Study participants will be randomly assigned to one of two treatment groups:
- Arm A (Standard Treatment): Chemo-radiation (standard radiation therapy plus cisplatin chemotherapy). Radiation therapy will be given over eight weeks. Cisplatin chemotherapy will be given in five treatments, weekly during the course of the radiation therapy. Following external radiation, intracavitary radiation (radiation delivered directly to the cervix through the vagina) will be administered.
- Arm B (Experimental): Will receive chemo-radition (radiation therapy plus cisplatin chemotherapy) followed by intracavitary radiation as in Arm A. Beginning 4 weeks later, will also receive adjuvant chemotherapy (carboplatin and paclitaxel) repeated every 3 weeks for 4 cycles.
Disease Status and/or Stage
Locally Advanced Cervical Cancer
Sponsor
Gynecologic Oncology Group; National Cancer Institute
Key Eligibility
- Women age 18 and older
- Locally advanced cervical cancer
- No prior chemotherapy for this tumor
- No prior pelvic radiotherapy
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Dr. Gupta
- (212) 746-3307
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For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
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