Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Smoking status
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Quality-of-Life Assessment
Other interventionComplete quality of life questionnaires
Questionnaire Administration
Other interventionComplete adverse event assessments
Radiation Therapy
RadiationUndergo proton or intensity modulated radiation therapy
Treatment groups
121 Participants
are divided into 1 treatment groupGroup A: Treatment (radiation therapy, questionnaires)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Will be examined using analysis of covariance.
Time frame
Baseline up to 3 years post-radiation therapy (RT)Secondary outcomes
1
Bowel and bladder dose-volume histogram (DVH) parameters
Will be examined in association with the change in EPIC Bowel and Urinary scores using analysis of covariance, considering the DVH variables as model covariates.
Time frame
Up to 3 years post-RT2
Change in EPIC Urinary score
Will be examined using analysis of covariance.
Time frame
Baseline up to 5 weeks3
Well-being
Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.
Time frame
Up to 3 years post-RT4
Incidence of grade 2+ hematologic toxicities
Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.
Time frame
Up to 3 years post-RTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov