Actively Recruiting
Comparison of Side Effects Between Proton and Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Led by Mayo Clinic · Updated on 2026-04-23
120
Participants Needed
3
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating and comparing the side effects of proton radiation therapy versus intensity modulated radiation therapy (IMRT) after surgery in patients with endometrial or cervical cancer. This early phase trial aims to determine if proton therapy is linked to fewer acute gastrointestinal toxicities at the end of treatment compared to IMRT. The study also explores effects on urinary toxicity, overall well-being, hematologic toxicities, survival rates, and quality of life using various validated questionnaires and assessments. Participants receive either proton therapy or IMRT to the pelvis, with or without para-aortic lymph node irradiation, using a rectal balloon during treatment at Mayo Clinic sites. Radiation is delivered post-surgery after a hysterectomy. Quality of life questionnaires and adverse event assessments are completed at baseline, the end of radiation therapy, then at 1 month, 1 year, and 3 years afterward to monitor outcomes and side effects. Throughout the study, patients undergo standard imaging and laboratory tests for staging, blood counts, and physical exams. Researchers measure bowel and bladder toxicities, urinary side effects, hematologic effects, treatment tolerance, and overall quality of life. Safety and progression-free survival are also tracked. The total follow-up extends up to three years post-radiation therapy, with regular questionnaires and adverse event monitoring to assess the impact of each radiation type.
CONDITIONS
Official Title
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of cervical or endometrial cancer
- Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium
- History and physical prior to registration
- Documentation of history of smoking status, pelvic infection, pelvic inflammatory disease, or endometriosis
- Planned to receive either proton or IMRT radiation treatment with use of rectal balloon at any Mayo Clinic site
- Plan for radiation therapy to pelvis with or without para-aortic lymph node irradiation
- If received high-dose chemotherapy prior to registration, last dose must have been given 21 or more days before start of radiation therapy
- Complete blood count performed within 21 days prior to registration
- CT, MRI, PET/CT, or PET/MRI for staging before registration, either pre-operative or post-operative
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Provide written informed consent
- Willing to complete quality of life questionnaires
You will not qualify if you...
- Receiving external beam boost dose during radiation therapy
- Presence of distant metastases
- Gross disease at time of radiation therapy
- Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma, or small cell carcinomas
- Patients exceeding weight or size limits of treatment table
- Positive or close surgical margins (less than or equal to 3 mm)
- Prior radiation therapy to the pelvis
- Planned to receive inguinal node radiation therapy
- Hepatic insufficiency causing clinical jaundice or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based on CDC definition
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for at least 3 years
- Severe active co-morbidity such as unstable angina or congestive heart failure requiring hospitalization within last 6 months
- Transmural myocardial infarction within last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at registration
- Other major medical illness requiring hospitalization or preventing study therapy at registration
- Unwillingness to have rectal balloon placed daily during radiation therapy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Active, Not Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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