Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound
Traditional transrectal ultrasound (TRUS) is a technique used to help determine the stage of rectal cancer. All patients at Memorial Sloan-Kettering Cancer Center with rectal cancer have an ultrasound at the beginning of their treatment to accurately determine the depth of penetration (how deep into the rectal wall the tumor goes) and lymph node involvement of their tumor. This information helps determine the best way to treat the patient's disease. Three-dimensional TRUS (3-D TRUS) is a new form of ultrasound that gives us all of the information of traditional ultrasound in addition to being able to view the tumor in 3-dimensions. This image can be stored and analyzed to evaluate the tumor size and volume as well as determine the unique shape of the tumor. Chemoradiotherapy before surgery is considered standard of care for most rectal cancers.
Currently, there is no accurate way to determine whether or not the tumor has responded to the pre-operative radiation therapy. The purpose of this study is to evaluate the response of rectal cancer to pre-operative chemotherapy and/or radiation therapy using 3-D TRUS to measure the volume of the tumor before and after chemoradiotherapy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound (3-D TRUS) - A Pilot Project|
- To measure the response of primary rectal cancer to neoadjuvant chemotherapy and/or radiation therapy using 3-D TRUS [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- To correlate these findings with post-operative pathologic examination [ Time Frame: 6 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Other: Transrectal ultrasound 3-D (TRUS)
Transrectal ultrasound (TRUS) is widely accepted as an accurate and effective technique for staging of rectal cancer. The decision to administer pre-operative chemotherapy/radiation therapy is often made based on the results of the TRUS. Three-dimensional TRUS (3-D TRUS) is a new modality that provides all of the information of traditional TRUS as well as the ability to provide three dimensional views of the tumor.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597610
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Martin Weiser, MD||Memorial Sloan Kettering Cancer Center|