Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel in Treating Patients with Stage II Endometrial Cancer after Surgery

Inclusion Criteria

• All patients must have undergone hysterectomy. Bilateral salpingo-oophorectomy is strongly encouraged but not mandatory
• Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional * The hysterectomy may be performed as per the surgeon’s preference including vaginally, laparoscopically, robotic, or open. A specific number of lymph nodes removed will not be utilized for eligibility, but the operative report should reflect that the procedure performed was consistent with the procedures described in the Gynecologic Oncology Group (GOG) Surgical Manual
• If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment computed tomography (CT)/magnetic resonance imaging (MRI) is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed
• All patients will be staged according to the Federation of Gynecology and Obstetrics (FIGO) 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories: * Age >= 18 years with 3 risk factors * Risk factors: ** Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer 1/2 myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology ** Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high- intermediate risk factors. ** Patients with serous or clear cell histology (with or without other high- intermediate risk factors) are eligible provided the disease is uterine- confined (with or without cervical stromal invasion or endocervical glandular involvement)
• Patients must have GOG performance status 0, 1, or 2
• Absolute neutrophil count (ANC) >= 1,500/mcl (equivalent to Common Toxicity Criteria [Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0] grade 1)
• Platelets >= 100,000/mcl (CTCAE v4.0 grade 0)
• Serum creatinine =< institutional upper limit normal (ULN), CTCAE v 4.0 grade 0 * Note: If serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min.
• Bilirubin =< 1.5 x ULN (CTCAE v4.0 grade 0)
• Serum glutamic-oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v4.0 grade 0)
• Alkaline phosphatase =< 2.5 x ULN (CTCAE v4.0 grade 0)
• Neuropathy (sensory and motor) =< CTCAE v4.0 grade 1
• Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
• Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria

• Patients with recurrent disease
• Patients with GOG performance status of 3 or 4
• Greater than 12 weeks elapsed from surgery to enrollment
• Patients have prior pelvic or abdominal radiation therapy
• Known hypersensitivity to any component of study treatments that resulted in drug discontinuation
• Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Active pregnancy or lactation
• Prior malignancy requiring treatment within the last 3 years