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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

Primary Objectives: To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. Secondary Objectives: To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events utilizing the active version of CTCAE. To provide assessment of patient risk vs. benefit (positive study only). Quality of Life Objectives: To determine whether post-operative adjuvant CRT improves the health related Quality of Life (QOL) (compared to RT alone) as measured by FACT-Cx TOI and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events). Translational Research Objectives: To bank archival tumor tissue for research including studies that evaluate the association between biomarkers and RFS, OS and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone. To bank DNA from whole blood for research including studies that evaluate associations between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including RFS, OS and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.

Primary Objectives: To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. Secondary Objectives: To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events utilizing the active version of CTCAE. To provide assessment of patient risk vs. benefit (positive study only). Quality of Life Objectives: To determine whether post-operative adjuvant CRT improves the health related Quality of Life (QOL) (compared to RT alone) as measured by FACT-Cx TOI and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events). Translational Research Objectives: To bank archival tumor tissue for research including studies that evaluate the association between biomarkers and RFS, OS and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone. To bank DNA from whole blood for research including studies that evaluate associations between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including RFS, OS and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.