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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT04567771
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality-of-Life Assessment — OTHER
    Complete quality of life questionnaires
  • Questionnaire Administration — OTHER
    Complete adverse event assessments
  • Radiation Therapy — RADIATION
    Undergo proton or intensity modulated radiation therapy

Study Details

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.

Key Dates

Start date
Dec 4, 2020
Status verified
Apr 2026
Primary completion
Oct 15, 2028
Completion
Oct 15, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score [ Time Frame: Baseline up to 3 years post-radiation therapy (RT) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Sujay A. Vora, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referra Office
[email protected]
855-776-0015
Allison E. Garda, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Cervical cancerEndometrial cancerEndometriosis
By specialty
OncologyGynecologic oncologyWomen's healthFertility
By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

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