Rectal Cancer Clinical Trial
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
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - biopsy proven rectal cancer (path confirmed at MSKCC) - able to provide consent for 3-D TRUS - eligible for pre-operative chemotherapy and/or radiation therapy Exclusion Criteria: - unable to provide informed consent - unable to tolerate 3-D TRUS either pre- or post-chemo/RT - unable to tolerate full course of chemotherapy and/or radiation therapy |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the response of primary rectal cancer to neoadjuvant chemotherapy and/or radiation therapy using 3-D TRUS | 6 years | No | |
Secondary | To correlate these findings with post-operative pathologic examination | 6 years | No |
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