Randomized Phase III Trial of Adjuvant Radiation vs. Chemo-radiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy
Patients are asked to be in this study who have already had an operation for early-stage cervical cancer. Cervical cancer is classified as low, intermediate, and high risk based on the pathology findings. Women with early cervical cancer with the most concerning pathology findings for recurrence of cancer or "high risk" are treated with radiation and chemotherapy. Patients with "intermediate risk" are treated with radiation alone. To reduce the risk of disease returning, preventative external radiation therapy will be given. In this study we will compare the effects of cisplatin and radiation therapy with radiation therapy alone on cervical cancer to find which works better to control the disease. Patients will get either standard treatment with radiation therapy OR standard treatment with radiation therapy with the addition of cisplatin chemotherapy.
The purpose of this study is to determine if weekly chemotherapy with cisplatin and simultaneous radiation therapy increases the time patients live disease-free compared to radiation therapy alone.
Another purpose of this study is to test samples of blood, as well as tumor samples if left over from recent surgery or a previous biopsy. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects, or have a good prognosis.
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Principle Investigator: Dr. Randolph Deger
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
Patients are being asked to take part in this study because they have cervical cancer that was removed by surgery and has spread to the lymph nodes or to the connective tissue of the uterus. The purpose of this study is to compare the effects, good and/or bad, of giving additional chemotherapy after the usual treatment of chemotherapy and radiation for cervical cancer. The standard treatment for this type of cervical cancer is cisplatin chemotherapy plus radiation. The study will determine whether adding chemotherapy with carboplatin and paclitaxel (experimental for this type of cervical cancer) to standard radiation and cisplatin chemotherapy improves survival without increasing side effects. Cisplatin, carboplatin, and paclitaxel are FDA (Food and Drug Administration) approved drugs used to treat a number of different types of cancers, however carboplatin and paclitaxel are experimental for the treatment of cervical cancer. In this study, patients will receive either radiation plus cisplatin alone or radiation plus cisplatin followed by carboplatin and paclitaxel.
One of the standard treatment options for this stage and type of cervical cancer is external beam radiation therapy. Both three-dimensional radiation therapy and IMRT allow the radiation beam to treat an area that is shaped like the tumor and also to penetrate as deeply as the tumor is located. By treating this way, the dose of radiation to the healthy areas near the tumor is minimized, and the dose to the tumor is maximized.
This study also will study biologic factors that may help to predict and treat cervical cancer. In addition, this study will gather information about the effects of radiation therapy and chemotherapy on the overall quality of life.
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Principle Investigator: Catherine Kim, M.D.
Contacts for Participation in Clinical Trials:
Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
Karen Goldsmith, BSN, RN
Maria Jenkins, CCRP
Clinical Research Coordinator