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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07415681
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Volume Modulated Arc Therapy (VMAT) — RADIATION
    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.
  • Intensity Modulated Proton Therapy (IMPT) — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2033

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Photon Radiation
    Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT))
  • Active Comparator: Proton Radiation
    Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))

Primary Outcome Measure

Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0 [ Time Frame: 2-years following completion of treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Maryland Proton Treatment CenterBaltimoreMaryland21201-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Upper Chesapeake HealthBel AirMaryland21014-
Central Maryland Radiation OncologyColumbiaMaryland21044-
Baltimore Washington Medical Center- Tate Cancer CenterGlen BurnieMaryland21061-

Find similar trials in Baltimore, MD

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Maryland Proton Treatment Center· Baltimore, MDUniversity of Maryland Greenebaum Cancer Center· Baltimore, MDUpper Chesapeake Health· Bel Air, MDCentral Maryland Radiation Oncology· Columbia, MDBaltimore Washington Medical Center- Tate Cancer Center· Glen Burnie, MD

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