Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT00120211 |
Recruitment Status
:
Completed
First Posted
: July 15, 2005
Last Update Posted
: October 13, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Radiation: Accelerated Radiotherapy Fractionation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 855 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer |
Study Start Date : | September 1998 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | May 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Radiotherapy: 6 Fractions |
Radiation: Accelerated Radiotherapy Fractionation
Radiation Therapy 6 fractions per week
|
Active Comparator: Radiotherapy: 5 fractions |
Radiation: Accelerated Radiotherapy Fractionation
Radiotherapy 5 fractions per week
|
- Three Years Loco-regional Control [ Time Frame: 3 years ]
- Disease-specific Survival [ Time Frame: 8 years ]
- Overall Survival [ Time Frame: 8 years ]
- Acute Adverse Effects
- Late Adverse Effects [ Time Frame: 8 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Head and Neck Cancer
Exclusion Criteria:
- Unable to give an informed consent

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): NCT00120211
Study Director: | Eduardo Rosenblatt, M.D. | International Atomic Energy Agency (IAEA) |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | International Atomic Energy Agency |
ClinicalTrials.gov Identifier: | NCT00120211 History of Changes |
Other Study ID Numbers: |
E33018 |
First Posted: | July 15, 2005 Key Record Dates |
Last Update Posted: | October 13, 2011 |
Last Verified: | October 2011 |
Additional relevant MeSH terms:
Head and Neck Neoplasms Neoplasms by Site Neoplasms |