Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck
This study is ongoing, but not recruiting participants.
Sponsor:
King Faisal Specialist Hospital & Research Center
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00534950
First received: September 24, 2007
Last updated: December 11, 2011
Last verified: December 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 24, 2007 | ||||
| Last Updated Date | December 11, 2011 | ||||
| Start Date ICMJE | September 2007 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
safety [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00534950 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Randomized multicenter study of 5 vs 6 weekly fraction of RT in the treatment of SCC of the head and neck |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Carcinoma, Squamous Cell | ||||
| Intervention ICMJE | Radiation: 5 vs 6 weekly fraction of RT
Chemotherapy |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | September 2015 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Saudi Arabia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00534950 | ||||
| Other Study ID Numbers ICMJE | RAC#0981-019 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | King Faisal Specialist Hospital & Research Center | ||||
| Study Sponsor ICMJE | King Faisal Specialist Hospital & Research Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | King Faisal Specialist Hospital & Research Center | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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