Back to resultsPilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
Primary Purpose
Rectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Chemotherapy, radiation therapy & surgery
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms focused on measuring Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
Eligibility Criteria
Inclusion Criteria:
- Patients with localized rectal CA
Sites / Locations
- KFSH&RC
Outcomes
Primary Outcome Measures
safety
Secondary Outcome Measures
Full Information
NCT ID
NCT00535041
First Posted
September 21, 2007
Last Updated
February 28, 2019
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00535041
Brief Title
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
Official Title
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Chemotherapy, radiation therapy & surgery
Intervention Description
radiation and chemotherapy
Primary Outcome Measure Information:
Title
safety
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with localized rectal CA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shouki Bazarbashi, MD
Organizational Affiliation
KFSH&RC
Official's Role
Principal Investigator
Facility Information:
Facility Name
KFSH&RC
City
Riyadh
ZIP/Postal Code
1211
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
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