Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
This study has been completed.
Sponsor:
International Atomic Energy Agency
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00120211
First received: July 8, 2005
Last updated: October 12, 2011
Last verified: October 2011
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Purpose
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Radiation: Accelerated Radiotherapy Fractionation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer |
Resource links provided by NLM:
Further study details as provided by International Atomic Energy Agency:
Primary Outcome Measures:
- Three Years Loco-regional Control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease-specific Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
- Acute Adverse Effects [ Designated as safety issue: Yes ]
- Late Adverse Effects [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 855 |
| Study Start Date: | September 1998 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Head and Neck Cancer
Exclusion Criteria:
- Unable to give an informed consent
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00120211
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120211
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
| Study Director: | Eduardo Rosenblatt, M.D. | International Atomic Energy Agency (IAEA) |
More Information
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 |
| Study First Received: | July 8, 2005 |
| Last Updated: | October 12, 2011 |
| Health Authority: | United Nations: International Atomic Energy Agency |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on September 30, 2016