Cervical CarcinomaRT-PACENCT05139368
Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer
A study testing Hypofractionated Radiation Therapy in people with Cervical Carcinoma and Endometrial Carcinoma, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Endometrial Carcinoma
- What is being tested?
- Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 26 Jun 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Cervical Carcinoma, Endometrial Carcinoma
- Being tested
- Hypofractionated Radiation Therapy
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Undergo hypofractionated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (hypo-fractionated radiotherapy) | Experimental | Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Change in urinary toxicity will be measured by the change in urinary summary 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. 10 items in this assessment create the Urine Summary score.
Urine 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 Urine 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 Urine Summary scores at the week 3 and 1 year timepoint.
Measured: 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
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.
Measured: Baseline to 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea)
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.
This outcome measure is a single item assessing how OFTEN participants experienced Loose or Watery Stools (Diarrhea) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Measured: 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
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.
This outcome measure is a single item assessing how OFTEN participants experienced Pain in the Abdomen (Belly Area) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Measured: 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
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.
This outcome measure is a single item assessing the SEVERITY of participants' Pain in the Abdomen (Belly Area) at its WORST in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Measured: 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) - INTERFERE Pain in the Abdomen
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.
This outcome measure is a single item assessing how much Pain in the Abdomen (Belly Area) INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Measured: 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 Lose Control of Bowel Movement
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.
This outcome measure is a single item assessing how OFTEN participants experienced Lose Control of Bowel Movement in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Measured: 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) - INTERFERE Loss of Control of Bowel Movement Interfere
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.
This outcome measure is a single item assessing how much Loss of Control of Bowel Movement Interfere INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Measured: 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 Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
To assess acute and 1 year quality of life following treatment as assessed on the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx).
FACT-Cx is a 42-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-Cx total scores range from 0-168, with higher scores indicating better Quality of Life (QOL) and lower scores indicating worse QOL This outcome measure will report the mean change in the FACT-Cx Total Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) timpoints.
A positive change indicates the scores increased (improved QOL), and a negative Change indicates the scores decreased (worse QOL).
Measured: 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 FACIT Measure of Financial Toxicity (FACIT-COST) Score
To assess acute and 1 year quality of life following treatment as assessed on the FACIT Measure of Financial Toxicity (FACIT-COST).
FACT-COST is a 12-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-COST Score ranges from 0-44, with higher scores indicating better financial well-being and lower scores indicating worse financial well-being. This outcome measure will report the mean change in the FACT-COST Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points.
A positive change indicates the scores increased (better financial well-being), and a negative Change indicates the scores decreased (worse financial well-being).
Measured: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Decision Regret Scale - Summary Score
To assess acute and 1 year satisfaction with decision-making following treatment.
The Decision Regret Scale is a 5-item, self-assessed questionnaire rated on a 5-point Likert scale. Decision Regret Scale Score ranges from 0-100, with higher scores indicating high regret and lower scores indicating less regret.
This outcome measure will report the mean Decision Regret Scale Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points.
Measured: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Overall Survival
Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.
Measured: Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start11 Nov 2021
- Primary completion17 Jul 2024
- Study completion26 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gita Suneja, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139368
- Sponsor's protocol ID
- 144462
- Other IDs
- NCI-2021-12258, HCI144462, P30CA042014
- Acronym
- RT-PACE
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2021
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05139368
- Acronym / sponsor ID
- RT-PACE / 144462
- Conditions
- Cervical Carcinoma, Endometrial Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 26 Jun 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (hypo-fractionated radiotherapy) | Experimental | Radiation: Hypofractionated Radiation TherapyPatients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Radiation TherapyAlso: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, HypofractionatedUndergo hypofractionated radiation therapy | Radiation | Treatment (hypo-fractionated radiotherapy) |
Primary outcome
Change in Toxicity - Bowel Summary Score
Time frame: from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit
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.
Trial Feasibility - Number of Evaluable Patients
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit)
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.
12 secondary outcomes
Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument
Time frame: 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
Time frame: Baseline to 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea)
Time frame: 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
Time frame: 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
Time frame: 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) - INTERFERE Pain in the Abdomen
Time frame: 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 Lose Control of Bowel Movement
Time frame: 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) - INTERFERE Loss of Control of Bowel Movement Interfere
Time frame: 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 Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
Time frame: 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 FACIT Measure of Financial Toxicity (FACIT-COST) Score
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Decision Regret Scale - Summary Score
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Overall Survival
Time frame: Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gita Suneja, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation Therapy in people with Cervical Carcinoma and Endometrial Carcinoma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Toxicity - Bowel Summary Score (time frame: from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.