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NCT04683653

Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved 9 months later.

See at-risk trials from University of Chicago

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Record History

All 11 versions: 10 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 20, 2026 to May 20, 2027 Show 5 more changesShow less
    • Recruitment resumed after suspension
    • Eligibility criteria expanded, about 13 words
    • Study completion pushed from Dec 20, 2026 to Dec 20, 2027
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised at 5 of 5 sites
  2. Recruitment suspended Sponsor's reason: Enrollment Goal Met
    • Study completion moved earlier from May 22, 2027 to Dec 20, 2026
    • Primary completion date changed from estimate of May 22, 2027 to Aug 20, 2026
    • Site details revised at 5 of 5 sites
    v10
  3. Primary completion date changed from estimate of May 22, 2027 to Aug 20, 2026v9
  4. Primary and study completion dates: May 22, 2025 to May 22, 2027
    • Study sites: 4 to 5
    v7
  5. Phase: Not applicable to Phase 1/2v6 Show 5 more changesShow less
    • Enrollment target: 40 to 100
    • Eligibility criteria expanded, about 7 words
    • Primary endpoints: 1 to 2
    • Study sites: 1 to 4
    • Secondary endpoints: 2 to 5
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates pushed to May 22, 2025v5
  2. Primary completion date: Feb 8, 2023 to May 22, 2023v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2021 to Jan 15, 2021
    v3
  4. Primary endpoint revised
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)
Timeframe: 3-5 weeks
Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)
Timeframe: 3-5 weeks (end of treament)

Secondary (5)

Change in patient-reported acute urinary side effects
Change in gastrointestinal toxicity over time
Overall quality of life after treatment
Financial Distress of Treatment
Treatment Satisfaction

Arms and interventions

Hypofractionated Radiation Treatment (Dose-Finding Arm)Experimental

All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer).

Expansion Cohort (Efficacy Arm)Experimental

Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment.

Radiation: Hypofractionated Radiation

Other: Clinical Follow-Up and Assessments

Sites

5 sites in 1 country