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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT04683653Sponsor: University of ChicagoLast updated: 2025-12-29

Summary

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).

Arms & interventions

  • RadiationHypofractionated 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.

  • OtherClinical Follow-Up and Assessments

    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.

Outcome measures

Primary

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

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

    Time frame: 3-5 weeks

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

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

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

Secondary

  • Change in patient-reported acute urinary side effects

    Time frame: 1 month post radiation

  • Change in gastrointestinal toxicity over time

    Time frame: 1 month post radiation

  • Overall quality of life after treatment

    Time frame: 2 years post treatment

  • Financial Distress of Treatment

    Time frame: End of treatment

  • Treatment Satisfaction

    Time frame: End of treatment

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (5)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

Active Not Recruiting

University of Illinois at Chicago (UIC)

Chicago, Illinois, 60612

Recruiting
Mercedes Carrasquillo · Contact
Christina Son · Principal Investigator

University of Chicago

Chicago, Illinois, 60637

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Rauda Alicia Cordova · Contact
Geena Mathew · Contact
Anuja Jhingran,, MD · Principal Investigator

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Recruiting
Gita Suneja, MD · Principal Investigator
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer | Cancerify