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

NCT00597610 | Completed DMC

• 1 other identifier: 03-127
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectum; Rectal

Outcome Measures

Primary Outcomes (1)

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

  6 years

Secondary Outcomes (1)

• To correlate these findings with post-operative pathologic examination

  6 years

Study Arms (1)

1

EXPERIMENTAL

Other: Transrectal ultrasound 3-D (TRUS)

Interventions

Transrectal ultrasound 3-D (TRUS) OTHER

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Martin Weiser, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: November 1, 2003
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)