Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cervical Carcinoma
  • Endometrial Carcinoma
  • Endometriosis
  • Pelvic Inflammatory Disease
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

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. SECONDA...

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.

Tracking Information

NCT #
NCT04567771
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ivy A Petersen Mayo Clinic in Rochester