GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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 criteria
Qualifiers
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
Histologic confirmation of malignancy (primary only)
≥ 18 years of age
ECOG performance status ≤ 2
Disqualifiers
Metastatic disease beyond para-aortic lymph nodal region
Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.
Cervical cancer with inability to receive concurrent chemotherapy.
Trial design
Treatments tested in this trial
- Volume Modulated Arc Therapy (VMAT)
- Intensity Modulated Proton Therapy (IMPT)
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov