An official website of the United States government
Comparison of Acute Toxicities between Patients Treated with Protons or Intensity Modulated Radiation Therapy after Surgery for the Treatment of Endometrial or Cervical Cancer
Trial Status: active
This clinical 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.
Inclusion Criteria
Age ≥ 18 years
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 Criteria
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
Patients with active and/or inflammatory irritable bowel disease
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04567771.
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.
