Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

Conditions
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Cervical Carcinoma, Endometrial Carcinoma

Intervention / Treatment
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* Radiation: Hypofractionated Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (hypo-fractionated radiotherapy)<br>Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. | Radiation: Hypofractionated Radiation Therapy<br>* Undergo hypofractionated radiation therapy<br>* Other names: Radiation, Hypofractionated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |