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Not yet recruiting NCT07415681

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

Phase II Interventional Gynaecologic Cancer Cervical Cancer Radiation Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Volume Modulated Arc Therapy (VMAT), Intensity Modulated Proton Therapy (IMPT).
Who it may be relevant to
Registry conditions: Gynaecologic Cancer, Cervical Cancer, Radiation Therapy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0 [Time frame: 2-years following completion of treatment]
Secondary outcome measures (6)
  • Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT [Time frame: 2-year following completion of treatment]
  • Number of patients with decreased lymphocyte values at first follow-up visit post radiation [Time frame: 3 months post completion of RT]
  • Number of patients with physician reported GI toxicities assessed by CTCAE v5 [Time frame: 2 years post radiation treatment]
  • Rates of treatment completion within scheduled time frame [Time frame: 2 years post treament]
  • GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE) [Time frame: 2 years post treatment completion]
  • Compare 2-year overall survival, local failure and distant failure [Time frame: 2 years post treatment completion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Maryland Proton Treatment Center — Baltimore
  • University of Maryland Greenebaum Cancer Center — Baltimore
  • Upper Chesapeake Health — Bel Air
  • Central Maryland Radiation Oncology — Columbia
  • Baltimore Washington Medical Center- Tate Cancer Center — Glen Burnie

Identifiers

NCT: NCT07415681 · HP-00116109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗