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NCT Number: NCT04683653

Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Winship Cancer Institute, Emory University, Atlanta, Georgia, 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

  • Diagnosis of primary cervical cancer or uterine cancer of any histology
  • Age ≥ 18 years.
  • Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO).
  • Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
  • Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
  • Eastern Cooperative Oncology Group (ECOG) PS≤ 2
  • Able to provide informed consent and willingness to sign an approved consent form

Exclusion criteria

  • Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
  • Concurrent (or other) chemotherapy occurring at the time of study.
  • Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
  • History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
  • Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
  • Recommendation to undergo para-aortic nodal irradiation.

Treatment and study plan

hypofractionated radiation

Radiation

Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less often. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.

Clinical Follow-Up and Assessments

Other

At each visit, the subject will be evaluated for any signs of their endometrial cancer or symptoms returning (clinical disease recurrence) and any negative side effects associated with their prior radiation treatment. Study participants will also be asked to fill out a survey regarding bowel/urinary habits and quality of life questionnaires (known as the "EPIC questionnaire") during these visits. The data collected during these clinical follow up visits will be used to determine how effective hypofractionated/shortened whole radiation therapy is for treating endometrial cancer.

Primary outcomes

  1. The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)

    Time frame: 3-5 weeks

    The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.

  2. Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)

    Time frame: 3-5 weeks (end of treament)

    Change in quality-of-life experience on the bowel and urinary domains

Secondary outcomes

  1. Change in patient-reported acute urinary side effects

    Time frame: 1 month post radiation

    Determined using frequency of reported events of urinary frequency, urinary incontinence, and urinary urgency on the Patient Reported Outcomes (PRO-CTCAE)

  2. Change in gastrointestinal toxicity over time

    Time frame: 1 month post radiation

    Determined using frequency of reported events of diarrhea and proctitis on the Patient Reported Outcomes (PRO-CTCAE)

  3. Overall quality of life after treatment

    Time frame: 2 years post treatment

    Total quality of life score from the Functional Assessment of Cancer Therapy (FACT)-General questionnaire will be calculated. A higher score indicates better quality of life.

  4. Financial Distress of Treatment

    Time frame: End of treatment

    Change in reported financial distress in patients as reported on the Functional Assessment of Chronic Illness Therapy- COST (FACIT-COST) questionnaire. Higher scores on scale of 0-5 indicates better financial wellbeing.

  5. Treatment Satisfaction

    Time frame: End of treatment

    We will characterize the measure of regret experienced in the study patients over time as reported on the Decision Regret Scale questionnaire. Higher scores on scale of 0-100 indicates high regret.

Study contacts

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

Christina Son, MD

CONTACT

[email protected]

773-702-6870

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2020
Registry last updated
Dec 29, 2025

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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