A Phase 2 interventional study of Volume Modulated Arc Therapy (VMAT) and Intensity Modulated Proton Therapy (IMPT) in Gynaecologic Cancer, Cervical Cancer and Radiation Therapy, sponsored by University of Maryland, Baltimore. Recruiting at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 116 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT))
Radiation: Volume Modulated Arc Therapy (VMAT)
Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))
Radiation: Intensity Modulated Proton Therapy (IMPT)
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.
Also known as: Arm 1
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.
Also known as: Arm 2
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
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
Plan to share: No
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University of Maryland, Baltimore