Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Nov 15, 2025
  • participants needed
    64
  • sponsor
    University of Utah
Updated on 7 January 2022
cancer
hysterectomy
tumor cells
adenocarcinoma

Summary

This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Description

PRIMARY OBJECTIVE:

I. To establish the trial as feasible and to assess the impact upon acute gastrointestinal toxicity in the third week of pelvic radiotherapy following a hypo-fractionated schedule.

SECODARY OBJECTIVES:

I. To estimate impact upon acute urinary toxicity. II. To estimate impact upon patient reported gastrointestional toxicity. III. To assess acute quality of life following treatment. IV. To quantify acute financial toxicity following treatment. V. To assess satisfaction with decision-making following treatment. VI. To assess the overall survival throughout 3 years of post-treatment follow-up.

OUTLINE

Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, and 6 months and then at 1, 2, and 3 years.

Details
Condition Cervical Carcinoma, Endometrial Carcinoma
Treatment hypofractionated radiation therapy
Clinical Study IdentifierNCT05139368
SponsorUniversity of Utah
Last Modified on7 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female subject aged >= 18 years
Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted
Patients must be status post hysterectomy for initial management of cervix or endometrial cancer
Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Life expectancy of > 2 years
Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required

Exclusion Criteria

Prior abdominal or pelvic irradiation
Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
Prior history of inflammatory bowel disease
The diagnosis of another malignancy within =< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason score =< 6)
Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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