A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Cancer Following Radical Hysterectomy

Protocol
10-173
Full Title
Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy (RTOG 0724/GOG 0724)
Phase
III
Purpose

The standard treatment for cervical cancer that has spread to pelvic lymph nodes or uterine tissue is radical hysterectomy followed by cisplatin and radiation therapy. Researchers want to know if adding the drugs carboplatin and paclitaxel to this regimen can improve survival without increasing side effects.

Patients in this study will be randomly assigned to receive cisplatin and radiation alone or followed by carboplatin/paclitaxel. They will also be asked about their quality of life during therapy.

Eligibility

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

  • Patients must have cervical cancer that has spread to nearby lymph nodes or tissue attached to the uterus, but has not spread to distant sites.
  • Patients must have had radical hysterectomy.
  • Patients may not have had prior systemic therapy for cervical cancer or radiation to the same area of the pelvis to be irradiated in this study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario Leitao at 212-639-7659.

Disease(s)
Cervical Cancer
Locations
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