RECRUITING

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

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Conditions

Cervical CarcinomaEndometrial CarcinomaEndometriosisPelvic Inflammatory Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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.

Official Title

A Comparison of Acute Toxicities Between Patients Treated with Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

Quick Facts

Study Start:2020-12-04
Study Completion:2025-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04567771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed diagnosis of cervical or endometrial cancer
  2. * Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium
  3. * History and physical prior to registration
  4. * Documentation of history of:
  5. * Smoking status
  6. * Pelvic infection
  7. * Pelvic inflammatory disease
  8. * Endometriosis
  9. * Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at an Institutional Review Board (IRB)-approved Mayo Clinic site
  10. * Plan for RT to pelvis with or without para-aortic lymph node irradiation
  11. * If received high-dose chemotherapy prior to registration, last dose must have been given \>= 21 days prior to start of RT
  12. * Complete blood count (CBC) performed within 21 days prior to registration
  13. * 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
  14. * Eastern Cooperative Oncology Group (ECOG) performance score 0-2
  15. * Provide written informed consent
  16. * Willing to complete quality of life (QOL) questionnaires
  1. * Receiving external beam boost dose during RT
  2. * Distant metastases
  3. * Gross disease at time of RT
  4. * Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
  5. * Patients who exceed the weight/size limits of the treatment table
  6. * Positive or close surgical margins (=\< 3 mm)
  7. * Prior RT to the pelvis
  8. * Planned to receive inguinal node RT
  9. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  10. * 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.
  11. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  12. * Severe, active co-morbidity defined as follows:
  13. * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  14. * Transmural myocardial infarction within the last 6 months
  15. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  16. * Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
  17. * Patients unwilling to have rectal balloon placed on a daily basis during RT

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Allison E. Garda, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Allison E. Garda, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-04
Study Completion Date2025-10-15

Study Record Updates

Study Start Date2020-12-04
Study Completion Date2025-10-15

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Carcinoma
  • Endometrial Carcinoma
  • Endometriosis
  • Pelvic Inflammatory Disease