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NCT Number: NCT07415681

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

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.

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Key information

Conditions

Gynaecologic Cancer Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Radiation Therapy Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Maryland Proton Treatment Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.
  • Insurance approval for IMPT

Exclusion criteria

  • 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.
  • Any prior pelvic radiation.
  • Treatment with other investigational agents.
  • Carcinosarcoma.
  • Creatine clearance <30 mL/m2
  • Unable to lie flat during or tolerate radiation.
  • Refusal to sign informed consent.
  • Any additional active cancer that would interfere with the primary study endpoints

Treatment and study plan

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.

Other names: Arm 1

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.

Other names: Arm 2

Primary outcomes

  1. Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0

    Time frame: 2-years following completion of treatment

    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.

Secondary outcomes

  1. Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT

    Time frame: 2-year following completion of treatment

    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.

  2. Number of patients with decreased lymphocyte values at first follow-up visit post radiation

    Time frame: 3 months post completion of RT

    To compare lymphocyte nadir at first follow-up visit after completion of radiation.

  3. Number of patients with physician reported GI toxicities assessed by CTCAE v5

    Time frame: 2 years post radiation treatment

    To compare physician reported GI outcomes between arms.

  4. Rates of treatment completion within scheduled time frame

    Time frame: 2 years post treament

    To compare rates of treatment completion within scheduled time frame between arms.

  5. GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE)

    Time frame: 2 years post treatment completion

    To compare GI, GU and hematologic grade 2 or higher late toxicity events between arms.

  6. Compare 2-year overall survival, local failure and distant failure

    Time frame: 2 years post treatment completion

    To compare 2-year overall survival, local failure and distant failure between arms.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Eggleston, MPH

CONTACT

[email protected]

410-369-5351

Elizabeth Nichols, MD

CONTACT

[email protected]

410-328-6080

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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