Ensayos clínicos

Inclusion Criteria:

• •  
• Age ≥ 18 years old.
• 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 Intensity-Modulated Radiation Therapy (IMRT) radiation treatment, with use of rectal balloon, at an IRB-approved Mayo Clinic site.
• Plan for radiation therapy (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 .       
• CBC performed within 21 days prior to registration.
• CT, MRI, PET/CT, or PET/MRI for staging before registration; may be pre-op or post-op.
• Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
• Provide written informed consent.
• Willing to complete QOL questionnaires.

Exclusion Criteria: 

• Receiving external beam boost dose during RT.
• Distant metastases.
• No 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.
• Patients with active irritable bowel disease.
• 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 CDC definition; note that 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.