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Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, March 2009
First Received: January 9, 2008   Last Updated: March 4, 2009   History of Changes
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597610
  Purpose

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.


Condition Intervention
Rectal Cancer
Other: Transrectal ultrasound 3-D (TRUS)

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To correlate these findings with post-operative pathologic examination [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: November 2003
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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.

Detailed Description:

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. The greatest limitation of TRUS is its operator-dependence. 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. This provides greater detail regarding the configuration of the tumor as well as the ability to calculate tumor volume. The results of 3-D TRUS are interpreted after the study and thus, operator-dependence is reduced. There are no currently accepted techniques that allow for objective and accurate assessment of a rectal tumor's response to pre-operative treatment short of post-operative pathologic evaluation. Our objectives are to evaluate the ability of 3-D TRUS to quantify the tumor's response to pre-operative radiation therapy and/or chemotherapy and to correlate these findings with post-operative pathologic examination of the specimen. These objectives can be accomplished with 2 ultrasounds, one before treatment and one before surgery. All patients with biopsy-proven (with pathology confirmed at MSKCC) rectal cancer are eligible for the study. The size, volume and depth of penetration and lymph node involvement will all be assessed during both ultrasound examinations. Our findings will then be compared to those found at post-operative pathologic examination. These data will then be analyzed to determine if 3-D TRUS was accurate in predicting the tumor's response to preoperative treatment.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597610

Contacts
Contact: Douglas Wong, MD wongd@mskcc.org

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Douglas Wong, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Wong, Douglas, MD/ Principal Investigator )
Study ID Numbers: 03-127
Study First Received: January 9, 2008
Last Updated: March 4, 2009
ClinicalTrials.gov Identifier: NCT00597610     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Rectum
Rectal

Study placed in the following topic categories:
Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009