Actively Recruiting
Comparison of Proton and Intensity-Modulated Radiation Therapy for Post-Surgery Treatment of Endometrial or Cervical Cancer
Led by Mayo Clinic · Updated on 2026-04-23
120
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the side effects of proton radiation therapy compared to intensity modulated radiation therapy (IMRT) in patients treated after surgery for endometrial or cervical cancer. This early phase I trial aims to determine if proton therapy is linked to fewer acute gastrointestinal side effects at the end of treatment, improving quality of life for patients. The study also examines urinary and hematologic toxicities, overall well-being, survival outcomes, and patient-reported quality of life using various questionnaires. Patients receive standard care with either proton radiation therapy or IMRT targeting the pelvis, with or without para-aortic lymph node irradiation. Treatment includes the use of a rectal balloon and is delivered at Mayo Clinic sites. Participants complete quality of life and adverse event questionnaires at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years after treatment to monitor effects over time. During the study, patients undergo assessments including blood counts and imaging scans done before registration. Researchers monitor bowel and bladder radiation doses and their relation to side effects, track progression-free and overall survival, and evaluate hematologic toxicities. Participation involves completing questionnaires taking 10-15 minutes at each time point. The total follow-up period extends up to 3 years post-radiation therapy to observe long-term outcomes and safety.
CONDITIONS
Brief 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
- Underwent open or robotic hysterectomy for carcinoma of the cervix or endometrium
- History and physical examination completed prior to registration
- Documentation of smoking status, pelvic infection, pelvic inflammatory disease, and endometriosis
- Planned to receive proton or intensity modulated radiation therapy with rectal balloon at Mayo Clinic
- Planned radiation therapy to pelvis with or without para-aortic lymph node irradiation
- If previously received high-dose chemotherapy, last dose at least 21 days before radiation therapy
- Complete blood count within 21 days prior to registration
- Imaging (CT, MRI, PET/CT, or PET/MRI) for staging before registration
- Eastern Cooperative Oncology Group performance score of 0 to 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 present at time of radiation therapy
- Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma, or small cell carcinomas
- Exceeding weight or size limits of treatment table
- Positive or close surgical margins (3 mm or less)
- Prior radiation therapy to the pelvis
- Planned radiation therapy to inguinal nodes
- Hepatic insufficiency causing jaundice or coagulation problems
- Acquired immune deficiency syndrome (AIDS) based on CDC definition
- Prior invasive malignancy unless disease-free for at least 3 years
- Severe active co-morbidities including unstable angina, recent heart attack, or active infection requiring IV antibiotics
- Other major medical illnesses requiring hospitalization or preventing study therapy
- Unwillingness to have rectal balloon placed daily during radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks
Participants undergo proton or intensity modulated radiation therapy and complete quality of life questionnaires and adverse event assessments at baseline and at the end of radiation therapy.
Visits at baseline and at the end of radiation therapy
Duration - Up to 3 years post-radiation therapy
Participants complete quality of life questionnaires and adverse event assessments at 1 month, 1 year, and 3 years post-radiation therapy to monitor long-term effects and outcomes.
3 visits (in-person or remote) at 1 month, 1 year, and 3 years post-radiation therapy
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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