The Impact of Patient Positioning and Use of Belly Board on Small Bowel and Urinary Bladder Volume Irradiated in Patients Receiving Radiotherapy for Rectal Cancer: A Prospective Phase II Study

June 10, 2010 updated by: Tel-Aviv Sourasky Medical Center

Radiotherapy has a significant impact on local control, disease free survival and overall survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is accompanied by side effects, mainly due to the inclusion of the small bowel and urinary bladder in the treatment fields.

Two major modalities have been pursued to reduce the volume of small intestine and urinary bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These procedures have failed implementation in daily clinical practice. The second modality aims to save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating the radiotherapy planning procedure. Using the belly board and changing the standard position from supine to prone could achieve this aim; in part due to gravitational displacement of the bowel. Several studies have evaluated the impact of positioning and use of belly board in patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but the prone position with belly board appears promising.

This study carefully evaluates the impact of patient's positioning and belly board on dose volume histogram of small bowel and urinary bladder

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy.

In contrast to previous studies, the clinical target volume and organ at risk will be contouring for three-dimensional planning. With the aid of modern imaging, correlation can be obtained between dose and volume (DVH) since both parameters have an impact on organ tolerance to ionizing radiation.

Thirty patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative will be included (15 patients from each group).

In addition to radiotherapy, the patients will receive concomitant chemotherapy.

Chemotherapy: The chemotherapy will consist of one of the following:

  1. Capecitabine (Xeloda) 825mg/m2 ×2/day, given every day of radiotherapy.
  2. 5FU continuous infusion 180 mg/m2, D1-5/week X 5

Radiotherapy:

The clinical target volume (CTV) for preoperative radiotherapy will include the entire rectum and regional lymph nodes. The following lymph nodes will be contoured: peri rectal, pre sacral, obturator, internal iliac and distal common iliac. The contouring of the rectum will start 1 cm above the anal verge until the sigmoid (average 15 cm).

The planning target volume will be included in the CTV + 5mm The following organs at risk will be contoured: small intestine, urinary bladder and femoral joints.

The prescription dose will be: 180cGy/day, 5 times a week for a total 5,040cGy (38b fraction over 6 weeks.

Each patient will undergo two simulations, one in the supine position on a flat table and another in the prone position on belly board. No contrast media will be used. The urinary bladder will be full in an attempt to push the small bowel away from the treatment volume. Three dimensional conformal radiotherapy planning will be done twice (one in each position). Three and four fields plan will be evaluate in each position. Therefore a comparison will be between four plains and the optimal plan will be chose for treatment..

The following parameters will be calculated:

  1. Total volume of the small bowel
  2. Total volume of urinary bladder
  3. Intersection of PTV Volume and of small bowel volume
  4. Intersection of PTV volume and of urinary bladder volume
  5. Volume of small bowel included in the treatment volume
  6. Volume of urinary bladder in the treatment volume

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • TASMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative

Exclusion Criteria:

  • No exclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose and irradiated volume of small bowel and urinary bladder
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Eliahu Gez, MD, TASMC
  • Study Chair: Elaihu Gez, MD, TASMC
  • Study Chair: Eliahu Gez, MD, TASMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-10-EG-0681-09-TLV-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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