Comparing proton and intensity modulated radiation therapy after surgery for cervical or endometrial 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
This study tests whether proton radiation therapy causes fewer side effects than intensity modulated radiation therapy in patients who have had surgery for cervical or endometrial cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT04567771 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the side effects of proton radiation therapy versus intensity modulated radiation therapy (IMRT) in patients who have undergone surgery for cervical or endometrial cancer. The primary goal is to determine if proton therapy results in fewer acute gastrointestinal toxicities compared to IMRT, using various quality of life questionnaires and adverse event assessments. Secondary objectives include examining urinary toxicity rates, overall patient well-being, and survival outcomes between the two treatment modalities. The study aims to provide insights into the tolerability of chemotherapy in conjunction with radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of cervical or endometrial cancer who have undergone surgery and are planned to receive either proton or IMRT radiation treatment.
Not a fit: Patients who have not undergone surgery or those with other types of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options with fewer side effects for patients undergoing radiation therapy for cervical or endometrial cancer.
How similar studies have performed: Other studies have explored radiation therapy techniques, but this specific comparison of proton therapy and IMRT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Active_not_recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Allison E. Garda, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.