Quantifying Radiation Induced Vaginal Stenosis

This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis.

The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.

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:

• leukocytes ≥2,500/mcL
• absolute neutrophil count ≥1,500/mcL
• platelets ≥100,000/mcL
• hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
• total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤3 × ULN
• alkaline phosphatase ≤2.5 × ULN
• creatinine <1.5 mg/dL INR and aPTT ≤1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)
• Age is > 18 years.
• Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:
• A stable regimen of highly active anti-retroviral therapy (HAART)
• No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
• A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests.

Exclusion criteria

• Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy.
• Patients with PALN nodal metastasis above the T12/L1 interspace.
• Patients who had a radical hysterectomy with positive PALNs are not eligible.
• Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
• Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
• Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin)

a. transcription mediated amplification (TMA) or branched DNA testing.

• History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's