Endometrial Carcinoma Clinical Trial
— RT-PACEOfficial 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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | November 15, 2027 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE) | estimate impact upon patient reported gastrointestinal toxicities | Baseline to week 3 and 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Decision Regret Scale- summary score | To assess satisfaction with decision-making following treatment. | At week 3 and 1 year | |
Secondary | 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 |
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