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

Launched by MAYO CLINIC · Sep 23, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at two types of radiation therapy—proton therapy and intensity-modulated radiation therapy (IMRT)—to see which one causes fewer side effects for women who have had surgery for endometrial or cervical cancer. Radiation therapy is a treatment that uses high-energy rays to kill cancer cells. The researchers want to find out if proton therapy leads to less discomfort in the stomach and intestines during treatment compared to IMRT. To do this, they will gather information from participants through questionnaires about their quality of life and any side effects they experience.

To be eligible for this trial, participants must be women aged 65-74 who have been diagnosed with cervical or endometrial cancer and have had surgery to remove the tumor. They must also be planning to receive either proton or IMRT radiation therapy. Participants will need to complete health assessments and answer questions about their medical history. If they join the study, they can expect to receive radiation therapy as part of their treatment, and they will be asked to fill out questionnaires to help the doctors understand their experience during the trial.

Gender

FEMALE

Eligibility criteria

• 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 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 Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (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