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EqualEstro - Pharma Solutions |
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How can you ensure |
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- Patient safety? Differences in treatments will effect
survival, relapse rates and morbidity.
- Detection of drug effect? The variability in radiation therapy
can drown out the signal from the drug.
- Minimal costs? Increasing patient populations
to achieve sufficient power to compensate
for this variability increases the cost of the trial.
- Credibility of the results? Regulatory bodies are
focusing more today on the quality
and comparability
of the radiation therapy provided in clinical trials.
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Hazard of protocol deviation |
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The graph demonstrates the differences in loco-regional control for patients included in the HeadSTART trial. These patients with
advanced head & neck cancer were treated with chemo-radiation therapy with or without the test drug.
A retrospective analysis showed that in 11% of the cases there was a deviation from the radiotherapy protocol leading to adverse impact on tumour control.
This leads to a 20% loss of loco-regional control for these patients after one year compared to patients who received radiotherapy according to protocol. |
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* Rischin D, Peters L, O’Sullivan B, Giralt J, Yuen K, Trotti A, Bernier J, Bourhis J, Henke M, Fisher R, Trans-Tasman Radiation Oncology Group. Phase III study of tirapazamine, cisplatin and radiation versus cisplatin and radiation for advanced squamous cell carcinoma of the head and neck. J Clin Oncol (Meeting Abstracts) 2008 26: LBA6008. |
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