Phase II study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). Cancer of the bowel in this location can be difficult to remove. Sometimes it requires surgery that brings a piece of the bowel through the skin and results in the need to wear a collection bag for their stool permanently (colostomy). Currently, the use of chemotherapy and radiation before surgery has made it easier to remove the cancer and has made it less likely that patients will need to wear a permanent collection bag for stool. However, chemotherapy and radiation may occasionally have bad side effects. In addition, this therapy may take up to three months to complete before removal of the cancer can occur. In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given. With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it. This type of radiation known as brachytherapy is commonly used for many other types of cancer including (prostate, esophageal, recurrent rectal cancer, sarcoma, esophageal cancer, and head and neck cancer). You are being asked to take part in this study because you: - Have rectal cancer - Your cancer has not spread to other areas of your body. How many people will be in this study? We are asking for 30 participants in this study.
- Haverectal cancer - Your rectal cancer has not spread to other areas of your body.
If you agree to be in this study, we will ask you to do the following things: - Allow us to look at your tumor with a short flexible scope and an ultrasound in your rectum before and after you receive radiation. This is standard of care for your type of tumor. - Allow small clips to be placed in your bowel to mark the cancer for the HDRBT. The clips will be placed in your bowel using a lighted tube (an endoscopic procedure). Placing clips is part of this study and is necessary for us to see the borders of your tumor. - Allow us to take a biopsy of cancer tissue from your tumor. This biopsy will help to confirm the diagnosis of your rectal cancer. Taking a biopsy is a standard procedure for people with rectal cancer. We also ask that you give us permission to take a small part of that biopsy to use in future research. There will be a section later on in this consent that will give you the opportunity to agree or not agree to participate in this optional use of some of your tumor biopsy. . - Give 1 tablespoon of blood before and 1 tablespoon of blood after your radiation treatment. Drawing blood is part of this study. - Have magnetic resonance imaging (MRI) and an FDG-PET/CT scans before, during, and after the HDRBT. These procedures are standard when evaluating and treating rectal cancer. - Allow us to deliver radiation (HDRBT) to your tumor with a probe that has been placed in your rectum. The procedure to deliver the radiation will take less than one hour and will be repeated once a day for 4 days. All treatments must take place at Johns Hopkins Hospital. Giving the radiation close to the tumor by placing a probe into your bowel is part of this study. - You will have a standard surgery to treat your cancer. You will sign a standard clinical consent for this procedure. - Fill out a quality of life questionnaire at different time periods throughout the study for up to 2 years. The quality of life questionnaires are part of this study. - Allow researchers to follow your progress for 2 years. This is part of this study.
05/24/2013 04:02 AM