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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-12258 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HCI144462 | Other Identifier | Huntsman Cancer Institute/University of Utah | |
| P30CA042014 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (hypo-fractionated radiotherapy) | Experimental | Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Undergo hypofractionated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in toxicity | Will be measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument. | Baseline to week 3 of pelvic radiotherapy |
| Ability to administer clinical trial to evaluate hypofractionated radiotherapy | Will be measured by percent of eligible patients who begin treatment that complete baseline visit and 3-week EPIC bowel domain questionnaire. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument | estimate impact on acute and 1 year urinary toxicity | Baseline to week 3 and 1 year |
| Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gita Suneja, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2026 | Apr 7, 2026 | 7 | ||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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estimate impact upon patient reported gastrointestinal toxicities |
| Baseline to week 3 and 1 year |
| Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) | To assess acute and 1 year quality of life following treatment. | Baseline to week 3 and 1 year |
| Change in COST-FACIT Measure of Financial Toxicity | To assess acute and 1 year quality of life following treatment | Baseline to week 3 and 1 year |
| Decision Regret Scale- summary score | To assess satisfaction with decision-making following treatment. | At week 3 and 1 year |
| Overall survival | Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment. | 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 |
| Jul 1, 2026 |
| 8 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D055585 |
| Physical Phenomena |