NCT04567771

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. 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.

Conditions

• Cervical Carcinoma
• Endometrial Carcinoma
• Endometriosis
• Pelvic Inflammatory Disease

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Complete quality of life questionnaires
OTHER	Questionnaire Administration	Complete adverse event assessments
RADIATION	Radiation Therapy	Undergo proton or intensity modulated radiation therapy

Timeline

• Start date: 2020-12-04
• Primary completion: 2028-10-15
• Completion: 2028-10-15
• First posted: 2020-09-28
• Last updated: 2025-11-14

Locations

3 sites across 1 country: United States