Head and Neck Carcinoma Clinical Trial
Official title:
IAEA-HypoX. A Randomized Multicenter Study of Accelerated Fractionated Radiotherapy With or Without the Hypoxic Radiosensitizer Nimorazole in the Treatment of Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to test the hypothesis that radiotherapy of head and neck carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a hypoxic radiosensitizer in association with accelerated fractionation, in an unselected patient population in a global environment.
Squamous cell carcinoma in the head & neck region (HNSCC) accounts for approximately 7% of
all cancers worldwide & around 75% of all HNSCC cases are seen in the less developed
countries.
Significant improvement in loco-regional control & disease specific survival by radiation
therapy could be achieved by reducing the overall treatment time by "Accelerated
Fractionation" schedule.
Modification of hypoxia by Nimorazole demonstrated significant improved local effect of
radiation with neither serious nor lasting side effects. So, it is expected that the optimal
treatment option is reducing the overall treatment time with concomitant use of Nimorazole.
Such treatment principle is optimal for testing in developing countries.
The aim of the study:
- To determine the possible therapeutic gain of using nimorazole given as a hypoxic
radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive
squamous cell carcinoma of the larynx, pharynx and oral cavity, and
- To determine whether the addition of Nimorazole to primary curative radiotherapy is
feasible and tolerable on a worldwide scale.
- To evaluate the tolerance, compliance and toxicity of using nimorazole.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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