GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Volume Modulated Arc Therapy (VMAT)
RadiationVMAT 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.
Intensity Modulated Proton Therapy (IMPT)
RadiationIMPT- 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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Photon RadiationActive comparator 1 intervention
Group B: Proton RadiationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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 treatment2
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 RT3
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 treatment4
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 treamentSponsors and contacts
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Source ClinicalTrials.gov