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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
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.
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.
Maryland Proton Treatment Center
Baltimore, Maryland, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Upper Chesapeake Health
Bel Air, Maryland, United States
Central Maryland Radiation Oncology
Columbia, Maryland, United States
Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0
To compare patient reported acute gastrointestinal toxicity specifically grade 2 or higher (CTCAE) diarrhea events between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
Time frame: 2-years following completion of treatment
Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT
To compare the incidence of grade 4 lymphopenia during radiation between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
Time frame: 2-year following completion of treatment
Number of patients with decreased lymphocyte values at first follow-up visit post radiation
To compare lymphocyte nadir at first follow-up visit after completion of radiation.
Time frame: 3 months post completion of RT
Number of patients with physician reported GI toxicities assessed by CTCAE v5
To compare physician reported GI outcomes between arms.
Time frame: 2 years post radiation treatment
Rates of treatment completion within scheduled time frame
To compare rates of treatment completion within scheduled time frame between arms.
Time frame: 2 years post treament
GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE)
To compare GI, GU and hematologic grade 2 or higher late toxicity events between arms.
Time frame: 2 years post treatment completion
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Baltimore Washington Medical Center- Tate Cancer Center
Glen Burnie, Maryland, United States
Compare 2-year overall survival, local failure and distant failure
To compare 2-year overall survival, local failure and distant failure between arms.
Time frame: 2 years post treatment completion