Active — Not RecruitingNot Applicable

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

United States120 participantsStarted 2020-12-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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 * Positive or close surgical margins (=\< 3 mm) * Prior RT to the pelv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing proton radiation therapy versus intensity modulated radiation therapy (IMRT) after surgery for endometrial or cervical cancer — can you explain what the practical difference between these two types of radiation is, and why it might matter for my specific situation?
2The trial is primarily measuring changes in bowel function using something called the EPIC Bowel score — does that mean bowel side effects are a known concern with post-surgical radiation for my type of cancer, and how do the two approaches typically compare in that regard?
3Since this trial is no longer actively enrolling new patients, is there any way for me to access the emerging findings, or are there similar studies still open that I could be considered for?
4Given that this study is listed as 'Phase NA,' which seems to mean it's a comparative effectiveness study rather than a drug safety trial, what does that mean for how much is already known about the safety of both radiation approaches being studied?
5Would you recommend I pursue one of these radiation approaches — proton therapy or IMRT — as part of my standard treatment plan regardless of trial participation, and if so, how would you decide which one is right for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score

Timeframe: Baseline up to 3 years post-radiation therapy (RT)

Trial details

NCT IDNCT04567771

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01

View on ClinicalTrials.gov More Cervical Carcinoma trials