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p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

NCT00525200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2012-12-21

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

5-Fluoruracil, Cisplatinum

5 FU 1000mg/m2; days 1-5; 3 cycles: q21 Cisplatin 80mg/m2; day 1; 3 cycles: q21

DRUG

Docetaxel

Docetaxel 75mg/m2, day 1; 3 cycles; q21

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Austrian Society Of Surgical Oncology

    collaborator OTHER

  • Daniela Kandioler

    lead OTHER

Principal Investigators

  • Daniela Kandioler, Prof., MBA · ASSO Representative, MUW, p53research Head

  • Johannes Zacherl, Prof. · Medical University of Vienna, MUV

  • Michael Hejna, Prof. · MUW

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-05-31
Completion
2012-12-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525200 on ClinicalTrials.gov