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

NCT01142713 | Unknown Phase 2

• 1 other identifier: TASMC-10-EG-0681-09-TLV-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Dose and irradiated volume of small bowel and urinary bladder

  30 months

Interventions

Patient Position During Radiotherapy RADIATION

Two simulations, one in the supine position on a flat table and another in the prone position on belly board

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

TASMC

Tel Aviv, Israel

Location

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

• Eliahu Gez, MD

  TASMC

  PRINCIPAL INVESTIGATOR

• Elaihu Gez, MD

  TASMC

  STUDY CHAIR

• Eliahu Gez, MD

  TASMC

  STUDY CHAIR

Central Study Contacts

Eliahu Gez, MD

CONTACT

+972-52-7360476; eliahug@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 11, 2010

Record last verified: 2010-02

Locations

IL (1)