Comparing proton and intensity modulated radiation therapy after surgery for cervical or endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Active not recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Active not 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.