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A Feasibility Study to Compare the Benefits of Endoscopic Tumor Clip Placement and 3T-MRI Simulation for Accurate Target Volume Definition for Rectal Cancer Patients Undergoing Pre-operative Chemoradiation


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

A Feasibility Study to Compare the Benefits of Endoscopic Tumor Clip Placement and 3T-MRI Simulation for Accurate Target Volume Definition for Rectal Cancer Patients Undergoing Pre-operative Chemoradiation


1. The use of endoscopically placed mucosal metal clips to define the superior and
inferior extent of the rectal tumor will improve the accuracy of tumor localization in
patients undergoing non-contrast CT simulation.

2. A 3T-MRI will provide a better localization of the rectal tumor and pelvic nodes
compared to non-contrast CT simulation for radiotherapy treatment planning.

3. By comparing these two novel methods to the standard procedure, we would be able to
define any difference between the three methods and obtain an estimate of the accuracy
and reliability of each method for the localization of the rectal tumor.


Inclusion Criteria:



- Patients with adenocarcinoma of the rectum stage as T3/4 N0/1/2 M0 undergoing
pre-operative chemoradiation

- Patients must be 18 years of age or greater

- Signed study-specific informed consent

- Not pregnant or lactating

Exclusion Criteria:

- Contraindication for radiotherapy or chemoradiation

- Contraindication for MRI scanning

- Prior chemotherapy or radiation therapy to the pelvis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the usefulness of Endoscopic clip placement and 3T-MRI imaging for accurate target volume definition in rectal cancer patients undergoing pre-operative chemoradiation.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

RECTAL MRI SIM 25409

NCT ID:

NCT01133340

Start Date:

June 2010

Completion Date:

January 2013

Related Keywords:

  • Rectal Cancer
  • RADIOTHERAPY
  • CT simulation
  • MRI simulation
  • Endoscopic clip placement
  • Rectal cancer
  • Accuracy of MRI Simulation for target delineation and planning
  • Rectal Neoplasms

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