A Phase III Clinical Trial of Adjuvant Radiation versus Chemoradiation in Patients with Intermediate-Risk, Stage I/IIA Cervical Cancer Treated with Surgery

Protocol
11-007
Full Title
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT 3 01101451)(GOG 263)
Phase
III
Purpose

The standard treatment for intermediate-risk stage I/IIA cervical cancer that has been surgically removed is radiation therapy after surgery to reduce the risk of cancer recurrence. The purpose of this study is to see if adding the chemotherapy drug cisplatin to radiation therapy further extends the time to disease recurrence compared with radiation therapy alone. The combination of chemotherapy and radiation therapy has been shown to extend survival in women with higher-risk cervical cancer, but its effectiveness in women with disease that has an intermediate risk of recurring is not known.

Patients will be randomly assigned to receive radiation therapy plus cisplatin or radiation therapy alone after surgery. They will also be asked to complete quality-of-life questionnaires asking how they feel physically and emotionally during cancer treatment. Researchers also want to know about patients’ smoking histories since cervical cancer is associated with smoking.

Eligibility

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

  • Patients must have stage I/IIA cervical cancer that was initially treated with a standard radical hysterectomy with pelvic lymphadenectomy.
  • Patients must be at intermediate risk of recurrence.
  • Patients must enter the study at least 3 weeks but no more than 8 weeks after surgery.
  • Patients may not have had prior chemotherapy or radiation therapy for cervical cancer.

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