p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer
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.
Timeline
- Start
- 2007-06
- Primary completion
- 2012-05
- Completion
- 2012-12
Publications
- Background Kandioler D et al. p53 adapted neoadjuvant therapy for esophageal cancer: pilot study. JCO, vol 25, 18S: 206s
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 1000 mg/m2 | — |