Radiation therapy options compared for newly diagnosed gynecologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 randomized trial comparing two standard radiation techniques—volume modulated arc therapy with photons (VMAT) and intensity-modulated proton therapy (IMPT)—in newly diagnosed gynecologic cancers. Participants are randomly assigned to receive one of the two treatments as part of their planned chemoradiation or definitive chemoradiation with a brachytherapy boost. The study aims to compare side effects and tolerability between the two approaches while maintaining standard-of-care treatment. Eligible patients are adults with newly diagnosed disease who meet specific surgical and treatment criteria and have appropriate insurance for IMPT. The trial is conducted at multiple Maryland sites with lead involvement from the University of Maryland, Baltimore.

Why it matters

Who can join: the full rules

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 capable of giving consent on the subject's behalf.
6. Insurance approval for IMPT

Exclusion Criteria:

1. Metastatic disease beyond para-aortic lymph nodal region
2. Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
3. FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.
4. Cervical cancer with inability to receive concurrent chemotherapy.
5. Any prior pelvic radiation.
6. Treatment with other investigational agents.
7. Carcinosarcoma.
8. Creatine clearance \<30 mL/m2
9. Unable to lie flat during or tolerate radiation.
10. Refusal to sign informed consent.
11. Any additional active cancer that would interfere with the primary study endpoints

Where it's running

• Maryland Proton Treatment Center
  Baltimore, Maryland, United States Recruiting
• University of Maryland Greenebaum Cancer Center
  Baltimore, Maryland, United States Recruiting
• Upper Chesapeake Health
  Bel Air, Maryland, United States Recruiting
• Central Maryland Radiation Oncology
  Columbia, Maryland, United States Recruiting
• Baltimore Washington Medical Center- Tate Cancer Center
  Glen Burnie, Maryland, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Nichols, MD — University of Maryland Medical Center/Maryland Proton Treatment Center
• Study coordinator: Elizabeth Nichols, MD
• Email: enichols1@umm.edu
• Phone: 410-328-6080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.