Back to resultsPhase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients with nasopharyngeal Carcinoma
Exclusion Criteria:
- Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA
Sites / Locations
- KFSH&RC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week.
Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week.
Outcomes
Primary Outcome Measures
safety and efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00535795
First Posted
September 24, 2007
Last Updated
February 28, 2019
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00535795
Brief Title
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Official Title
A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
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
Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA
Detailed Description
It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week.
Arm Title
2
Arm Type
Experimental
Arm Description
Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation Therapy
Primary Outcome Measure Information:
Title
safety and efficacy
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with nasopharyngeal Carcinoma
Exclusion Criteria:
Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Al Rajhi, 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
Plan to Share IPD
Undecided
Learn more about this trial
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
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