Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer

NCT05139368 | Active Not Recruiting Results DMC FDA Device

• 4 other identifiers: 144462NCI-2021-12258HCI144462P30CA042014
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Carcinoma; Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in Toxicity - Bowel Summary Score

  Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.

  from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit

• Trial Feasibility - Number of Evaluable Patients

  To assess the feasibility of administering a clinical trial to evaluate hypofractionated radiotherapy. This outcome measure will report the number of evaluable patients and the number of patients who started study treatment but were not deemed evaluable. To be considered evaluable, an eligible patient must have completed 3 weeks of treatment and completed EPIC bowel domain questionnaire at baseline and 3 weeks.

  Baseline to week 3 (up to 6 weeks from the baseline visit)

Secondary Outcomes (12)

• Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument

  Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

• Change in Bowel Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument

  Baseline to 1 year (up to 14 months from the baseline visit)

• Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea)

  Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

• Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen

  Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

• Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen

  Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

Study Arms (1)

Treatment (hypo-fractionated radiotherapy)

EXPERIMENTAL

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

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Treatment (hypo-fractionated radiotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 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

You may not qualify if:

• Prior abdominal or pelvic irradiation
• Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame.
• 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, or bladder or of the cervix)
• 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

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Radiation Dose Hypofractionation; Radiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: IIT Data Management Team
• Organization: Research Compliance Office, Huntsman Cancer Institute

IITDataManagement@hci.utah.edu

801-213-6215

Study Officials

• Gita Suneja, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: November 11, 2021
• Primary Completion: July 17, 2024
• Study Completion (Estimated): June 26, 2027
• Last Updated: September 4, 2026
• Results First Posted: September 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)