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

Who is this study for? Adult female patients with Cervical or Endometrial Cancer that have undergone open or robotic hysterectomy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
ACTIVE_NOT_RECRUITING
Jacksonville
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2020-12-04
Estimated Completion Date: 2028-10-15
Participants
Target number of participants: 120
Treatments
Experimental: Treatment (radiation therapy, questionnaires)
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov