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
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Patient Position During Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Small Bowel Radiotherapy Dose, This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy
Eligibility Criteria
Inclusion Criteria:
- patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative
Exclusion Criteria:
- No exclusion
Sites / Locations
- TASMC
Outcomes
Primary Outcome Measures
Dose and irradiated volume of small bowel and urinary bladder
Secondary Outcome Measures
Full Information
NCT ID
NCT01142713
First Posted
June 10, 2010
Last Updated
June 10, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01142713
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
Brief Summary
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
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:
Capecitabine (Xeloda) 825mg/m2 ×2/day, given every day of radiotherapy.
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:
Total volume of the small bowel
Total volume of urinary bladder
Intersection of PTV Volume and of small bowel volume
Intersection of PTV volume and of urinary bladder volume
Volume of small bowel included in the treatment volume
Volume of urinary bladder in the treatment volume
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Small Bowel Radiotherapy Dose, This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Patient Position During Radiotherapy
Intervention Description
Two simulations, one in the supine position on a flat table and another in the prone position on belly board
Primary Outcome Measure Information:
Title
Dose and irradiated volume of small bowel and urinary bladder
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative
Exclusion Criteria:
No exclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliahu Gez, MD
Phone
+972-52-7360476
Email
eliahug@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliahu Gez, MD
Organizational Affiliation
TASMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elaihu Gez, MD
Organizational Affiliation
TASMC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eliahu Gez, MD
Organizational Affiliation
TASMC
Official's Role
Study Chair
Facility Information:
Facility Name
TASMC
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eliahu Gez, MD
12. IPD Sharing Statement
Learn more about this trial
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
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