p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Study Hypothesis:
PANCHO is a prospective randomized, predictive marker study, evaluating the interaction
between the potential predictive marker 'p53 genotype' and response to induction chemotherapy
in patients with esophageal cancer considered resectable.
170 patients with measurable disease will be enrolled in this study. After testing the marker
genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to
histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned
to receive 3 cycles of either 5-fluorouracil (5FU)/cisplatin or docetaxel monotherapy as
neoadjuvant therapy. All patients will be rendered to subsequent surgery in order to assess
both clinical and pathohistological response.
Phase:
Phase 3
Details
Lead Sponsor:
Daniela Kandioler
Collaborators:
Austrian Society Of Surgical Oncology Medical University of Vienna