Trial Parameters
Brief Summary
Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements. In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.
Eligibility Criteria
Inclusion Criteria: * Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II). * Patients must have normal organ and marrow function as defined below: 1. leukocytes ≥2,500/mcL 2. absolute neutrophil count ≥1,500/mcL 3. platelets ≥100,000/mcL 4. hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study) 5. total bilirubin ≤1.5 × institutional upper limit of normal (ULN) 6. AST(SGOT)/ALT(SGPT) ≤3 × ULN 7. alkaline phosphatase ≤2.5 × ULN 8. creatinine \<1.5 mg/dL INR and aPTT ≤1.