Status:
RECRUITING
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Cervical Carcinoma
Endometrial Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
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 ther...
Eligibility Criteria
Inclusion
- 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
- Endometriosis
- Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site
- Plan for RT 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 days prior to start of RT
- Complete blood count (CBC) performed within 21 days prior to registration
- Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT, or PET/MRI for staging before registration; may be pre-operative (op) or post-op
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Provide written informed consent
- Willing to complete quality of life (QOL) questionnaires
Exclusion
- Receiving external beam boost dose during RT
- Distant metastases
- Gross disease at time of RT
- Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
- Patients who exceed the weight/size limits of the treatment table
- Positive or close surgical margins (=\< 3 mm)
- Prior RT to the pelvis
- Planned to receive inguinal node RT
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
- Patients unwilling to have rectal balloon placed on a daily basis during RT
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04567771
Start Date
December 4 2020
End Date
October 15 2028
Last Update
November 14 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905