Head and Neck Clinical Trials to Know

Question 1

4 Phases of Clinical Trials

Answer 1

Phase I – Tolerance and Pharmacologic properties; determine spectrum of Toxicity,
ENDPOINT = maximally tolerated dose
HEALTHY SUBJECTS

Phase II – Efficacy of a drug in a specific Disease and Stage at a defined Dose; define Activity within tolerable levels of toxicity,
ENDPOINT = Response Rate
PATIENTS

Phase III – Comparison of 2 therapies in a Randomized manner;
ENDPOINT = Response Rate, Response Duration, Disease Free Survival, Overall Survival
PATIENTS

Phase IV: post release to assess long term complications.
PATIENTS

Question 2

RECIST (Response Evaluation Criteria in Solid Tumours) Criteria (4) “CPPS”

Answer 2

Complete Response = Disappearance of all target lesions (pathological LNs have reduction to <10mm short axis)

Partial Response = 30% decrease in sum of diameters of target lesions

Progressive Disease = 20% increase in sum of diameters of target lesions + absolute inclrease of 5mm

Stable Disease = not progressive or responsive