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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
Primary:
To determine if adjuvant systemic chemotherapy following chemoradiation therapy will improve disease-free survival compared to chemoradiation therapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after a radical hysterectomy.
Secondary:
To evaluate adverse events
To evaluate overall survival
To evaluate quality of life
To evaluate chemotherapy-induced neuropathy
To perform a post-hoc dose-volume evaluation between cases treated with standard RT and cases treated with IMRT with respect to toxicity and local control
To collect fixed tissue to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival
To collect blood to:
- Identify secreted factors from serum and plasma that may be associated with adverse events or outcome, and
- Identify SNPs in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy
Primary:
To determine if adjuvant systemic chemotherapy following chemoradiation therapy will improve disease-free survival compared to chemoradiation therapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after a radical hysterectomy.
Secondary:
To evaluate adverse events
To evaluate overall survival
To evaluate quality of life
To evaluate chemotherapy-induced neuropathy
To perform a post-hoc dose-volume evaluation between cases treated with standard RT and cases treated with IMRT with respect to toxicity and local control
To collect fixed tissue to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival
To collect blood to:
- Identify secreted factors from serum and plasma that may be associated with adverse events or outcome, and
- Identify SNPs in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy
Recruitment Status
Past Studies