A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries
University of Maryland, Baltimore
Summary
The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. a. Newly diagnosed endometrial cancer after TAH/BSO and nodal sampling, sentinel LN biopsy or pelvic nodal dissection planning to receive sequential chemotherapy and radiation or concurrent chemoradiotherapy or b. cervical cancer planning to receive definitive chemoradiation with HDR brachytherapy boost 2. Histologic confirmation of malignancy (primary only) 3. ≥ 18 years of age 4. ECOG performance status ≤ 2 5. Patient must have the ability to understand and the willingness to sign a written informed consent document or when appropriate, have an acceptable surrogate ca…
Interventions
- RadiationVolume Modulated Arc Therapy (VMAT)
VMAT RT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.
- RadiationIntensity Modulated Proton Therapy (IMPT)
IMPT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.
Locations (5)
- Maryland Proton Treatment CenterBaltimore, Maryland
- University of Maryland Greenebaum Cancer CenterBaltimore, Maryland
- Upper Chesapeake HealthBel Air, Maryland
- Central Maryland Radiation OncologyColumbia, Maryland
- Baltimore Washington Medical Center- Tate Cancer CenterGlen Burnie, Maryland