Study on Different Radiation Treatments for Early Stage Endometrial Cancer and Their Effects on Sexual Health

Sponsor: Kara Romano, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03785288

Provider View

This clinical trial is comparing two standard radiation treatments for early stage endometrial cancer to see how they affect sexual health. The study will look at the effects of high dose radiation given in different ways after surgery.

Patient Parameters

Program Overview

The aim of this study is to compare the effects of two different radiation treatments on sexual health in patients with early stage endometrial cancer. The treatments involve high dose radiation (HDR) given in two different ways: one with 3 sessions of 7 Gy and the other with 6 sessions of 4 Gy. Both treatments are given 4 to 12 weeks after surgery. Patients can choose to switch to the other treatment if they prefer. All participants will use a vaginal dilator after treatment to help with healing. Follow-up assessments will be done at 3 months, 1 year, and 2 years.

Description

Participants in this study will be randomly assigned to one of two radiation treatment groups after their surgery for early stage endometrial cancer. One group will receive high dose radiation (HDR) in 3 sessions of 7 Gy, while the other group will receive HDR in 6 sessions of 4 Gy. The radiation is given 4 to 12 weeks after surgery. Patients have the option to switch to the other treatment if they prefer. After treatment, all participants will use a vaginal dilator to help with healing. Follow-up assessments will be conducted at 3 months, 1 year, and 2 years to monitor the effects on sexual health.

Eligibility Criteria

Inclusion Criteria

  • Willing to provide written consent and follow the study protocol.
  • Have had surgery involving removal of the uterus and ovaries, with or without lymph node removal.
  • Diagnosed with early stage (Stage I-II) endometrial cancer, including all subtypes.
  • No remaining cancer after surgery.
  • ECOG performance status of 0-2, indicating good overall health.
  • Aged 18 years or older.
  • Expected to live at least 12 more months.

Exclusion Criteria

  • More advanced cancer (Stage III-IV) or needing additional radiation or chemotherapy.
  • Previous pelvic radiation or planned additional pelvic radiation.
  • Not recovered from side effects of previous treatments given more than 4 weeks ago.
  • Need more than 14 weeks between surgery and starting radiation, unless receiving chemotherapy.
  • Currently taking or recently took investigational drugs.
  • Unable or unwilling to participate in study procedures.
  • Pregnant or breastfeeding.
  • Prisoners.
  • Serious uncontrolled medical conditions that could affect treatment.
  • History of brain disease, uncontrolled seizures, or recent stroke.

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