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Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transrectal ultrasound 3-D (TRUS)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer focused on measuring Rectum, Rectal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To measure the response of primary rectal cancer to neoadjuvant chemotherapy and/or radiation therapy using 3-D TRUS

Secondary Outcome Measures

To correlate these findings with post-operative pathologic examination

Full Information

First Posted
January 9, 2008
Last Updated
September 26, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00597610
Brief Title
Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectum, Rectal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Transrectal ultrasound 3-D (TRUS)
Intervention 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. 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.
Primary Outcome Measure Information:
Title
To measure the response of primary rectal cancer to neoadjuvant chemotherapy and/or radiation therapy using 3-D TRUS
Time Frame
6 years
Secondary Outcome Measure Information:
Title
To correlate these findings with post-operative pathologic examination
Time Frame
6 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Weiser, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

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Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound

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