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Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA

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ClinicalTrials.gov Identifier: NCT00535795
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center

Brief Summary:
Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Radiation Therapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Study Start Date : September 2007
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week.
Radiation: Radiation Therapy
Radiation Therapy
Experimental: 2
Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week.
Radiation: Radiation Therapy
Radiation Therapy



Primary Outcome Measures :
  1. safety and efficacy [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with nasopharyngeal Carcinoma

Exclusion Criteria:

  • Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535795


Locations
Saudi Arabia
KFSH&RC
Riyadh, Saudi Arabia, 1211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Nasser Al Rajhi, MD KFSH&RC

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00535795     History of Changes
Other Study ID Numbers: RAC#0971-004
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: December 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases