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A Phase III Trial of Pelvic Radiation Therapy Versus Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

To determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy. To compare survival between the two treatment groups. To compare patterns of failure between the two treatment groups. To compare physical functioning, fatigue and neurotoxicity between the two treatment groups. To examine associations between primary comorbid illnesses and obesity on survival, fatigue and physical functioning. To evaluate the psychometric properties (such as construct validity, reliability, sensitivity to treatment and responsiveness over time) of the PROMIS Fatigue Short form 1, and to evaluate fatigue measurement equivalence between women with endometrial cancer and age-matched women from the general US population. To evaluate the ability of gene expression signatures in early stage endometrial cancer to predict recurrence and to explore the association between gene expression signatures in early stage endometrial cancer and clinical characteristics and outcome. To bank whole blood specimens for future research.

To determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy. To compare survival between the two treatment groups. To compare patterns of failure between the two treatment groups. To compare physical functioning, fatigue and neurotoxicity between the two treatment groups. To examine associations between primary comorbid illnesses and obesity on survival, fatigue and physical functioning. To evaluate the psychometric properties (such as construct validity, reliability, sensitivity to treatment and responsiveness over time) of the PROMIS Fatigue Short form 1, and to evaluate fatigue measurement equivalence between women with endometrial cancer and age-matched women from the general US population. To evaluate the ability of gene expression signatures in early stage endometrial cancer to predict recurrence and to explore the association between gene expression signatures in early stage endometrial cancer and clinical characteristics and outcome. To bank whole blood specimens for future research.