An interventional study of Quality-of-Life Assessment and Questionnaire Administration in Cervical Carcinoma, Endometrial Carcinoma and Endometriosis, sponsored by Mayo Clinic. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.
PRIMARY OBJECTIVE:
I. To assess whether proton radiation therapy (RT) is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT) as measured with the Expanded Prostate Cancer Index Composite (EPIC) bowel domain.
SECONDARY OBJECTIVES:
I. To examine the association of bowel and bladder dose-volume histogram (DVH) with bowel and bladder toxicities, respectively.
II. To assess whether urinary toxicity rate is improved with proton RT compared to IMRT as measured with the EPIC urinary domain.
III. To determine if well-being is improved with proton RT compared to IMRT as measured by the Functional Assessment of Cancer Therapy (FACT) cervix domain.
IV. To determine if proton RT reduces grade 2+ hematologic toxicities (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) compared to IMRT.
V. Evaluate progression-free and overall survival between patients receiving proton RT and IMRT.
VI. To determine if proton RT improves overall patient quality of life compared to IMRT using the European Quality of Life Five Dimension (EQ-5D) questionnaire.
EXPLORATORY OBJECTIVES:
I. Evaluate ability to tolerate chemotherapy concurrent or after RT. II. Correlate bone marrow DVH with blood marrow function, and ability to tolerate chemotherapy concurrently or after RT.
III. Correlate bowel and skin DVH with acute toxicity. IV. To evaluate patient-reported gastrointestinal (GI) toxicities as a predictor of assigned treatment regimen, as well as physician-reported GI toxicities as a predictor of assigned treatment regimen.
V. Confirm the validity of the EPIC bowel and urinary domains when referencing the last 7 days.
OUTLINE:
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
Documentation of history of:
Exclusion Criteria:
Severe, active co-morbidity defined as follows:
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Radiation Therapy
Complete quality of life questionnaires
Also known as: Quality of Life Assessment
Complete adverse event assessments
Undergo proton or intensity modulated radiation therapy
Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Will be examined using analysis of covariance.
Time frame: Baseline up to 3 years post-radiation therapy (RT)
Bowel and bladder dose-volume histogram (DVH) parameters
Will be examined in association with the change in EPIC Bowel and Urinary scores using analysis of covariance, considering the DVH variables as model covariates.
Time frame: Up to 3 years post-RT
Change in EPIC Urinary score
Will be examined using analysis of covariance.
Time frame: Baseline up to 5 weeks
Well-being
Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.
Time frame: Up to 3 years post-RT
Incidence of grade 2+ hematologic toxicities
Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.
Time frame: Up to 3 years post-RT
Progression-free survival
Will be examined using survival methods. Cumulative probability of progression rates will be calculated treating death as a competing risk. Cox models will be used to assess the association of treatment received (proton RT versus intensity modulated radiation therapy \[IMRT\]).
Time frame: Up to 3 years post-RT
Overall survival (OS)
Will be examined using survival methods. Estimates of OS will be calculated using the Kaplan Meier method. Cox models will be used to assess the association of treatment received (proton RT versus IMRT).
Time frame: Up to 3 years post-RT
Change in overall patient quality of life
Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be examined using analysis of covariance.
Time frame: Baseline up to 3 years post-RT
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