Brief Title
Comparison of Toxicities Between Proton Therapy and IMRT for Post Operative Treatment of Endometrial or Cervical Cancers.
Official Title
A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy (IMRT) for Post-Operative Treatment of Endometrial or Cervical Cancers
Brief Summary
This trial is designed as a non-randomized pilot trial to study, in a preliminary fashion,
whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the
end of treatment compared to intensity modulated radiation therapy (IMRT)
Study Type
Observational
Primary Outcome
To assess whether proton RT is associated with lower acute gastrointestinal toxicities at the end of treatment compared to IMRT as measured with the EPIC bowel domain.
Secondary Outcome
To examine the association of bowel and bladder dose-volume histogram (DVH) with bowel and bladder toxicities, respectively.
Condition
Cervical Cancer
Study Arms / Comparison Groups
Proton RT
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
120
Start Date
December 7, 2020
Completion Date
December 2023
Primary Completion Date
December 2023
Eligibility Criteria
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 an IRB-approved 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
CBC performed within 21 days prior to registration.
CT, MRI, PET/CT, or PET/MRI for staging before registration; may be pre-op or post-op
ECOG Performance Score (Appendix B) 0-2
Provide written informed consent
Willing to complete 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 CDC definition; note that 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 507-293-1275, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04745650
Organization ID
19-004792
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
, ,
Verification Date
February 2021