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This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy: 6 Fractions | Experimental |
| |
| Radiotherapy: 5 fractions | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated Radiotherapy Fractionation | Radiation | Radiation Therapy 6 fractions per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Three Years Loco-regional Control | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-specific Survival | 8 years | |
| Overall Survival | 8 years | |
| Acute Adverse Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Rosenblatt, M.D. | International Atomic Energy Agency (IAEA) | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20382075 | Derived | Overgaard J, Mohanti BK, Begum N, Ali R, Agarwal JP, Kuddu M, Bhasker S, Tatsuzaki H, Grau C. Five versus six fractions of radiotherapy per week for squamous-cell carcinoma of the head and neck (IAEA-ACC study): a randomised, multicentre trial. Lancet Oncol. 2010 Jun;11(6):553-60. doi: 10.1016/S1470-2045(10)70072-3. Epub 2010 Apr 8. |
| Label | URL |
|---|---|
| International Atomic Energy Agency, Research Contracts Administration | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Accelerated Radiotherapy Fractionation | Radiation | Radiotherapy 5 fractions per week |
|
| Late Adverse Effects | 8 years |