At a glance
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A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Pelvic Radiation, and 3 other interventions for Endometrial Cancer. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
Primary Objectives: * To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival. * To evaluate the toxicity of Paclitaxel and pelvic radiation. * To collect and evaluate patients' quality of life/symptom assessment data.
Study Details
Timeline
Interventions
50 mg/m\^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m\^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.
Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.
20 mg IV given 30 minutes prior to chemotherapy
300 mg IV given 30 minutes prior to chemotherapy
50 mg IV given 30 minutes prior to chemotherapy