GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries

Purpose

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.

Conditions

  • Gynaecologic Cancer
  • Cervical Cancer
  • Radiation Therapy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Photon Radiation 		Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT))
  • Radiation: Volume Modulated Arc Therapy (VMAT)
    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.
    Other names:
    • Arm 1
Active Comparator
Proton Radiation 		Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))
  • Radiation: Intensity Modulated Proton Therapy (IMPT)
    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.
    Other names:
    • Arm 2

Recruiting Locations

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Caitlin Eggleston, BS
4103287586
caitlineggleston@umm.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Elizabeth Nichols, MD
410-328-6080
enichols1@umm.edu