p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial
PANCHO will test the hypothesis that p53 genotype is predictive for response to
chemotherapy. The study uses the marker by treatment interaction design. In this design, we
assume that the status of the marker splits the whole population into two distinct groups
(p53 normal versus p53 mutant).
Patients in each marker group are randomly assigned to two different treatments, and planned
statistical analysis is to test whether one treatment is superior to the other within each
marker group separately.
The marker information but not the treatment is blinded to the patient and the
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype
Daniela Kandioler, Prof., MBA
ASSO Representative, MUW, p53research Head
Austria: Federal Ministry for Health and Women