p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer (PANCHO)

December 20, 2012 updated by: Daniela Kandioler

p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 investigators.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Leoben, Austria, 8790
        • Landeskrankenhaus Leoben
      • Linz, Austria, 4020
        • Krankenhaus der Elisabethinen
      • Stankt Veit, Austria, 9300
        • Krankenhaus der Barmherzigen Brüder
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Vienna, Austria, 1030
        • Rudolfstiftung
      • Vienna, Austria
        • Wilhelminenspital
      • Vienna, Austria, 1140
        • Hanusch Krankenhaus
      • Vienna, Austria, 1100
        • Kaiser Franz Josef Spital
      • Vienna, Austria
        • SMZ OST
    • Lower Austria
      • St. Polten, Lower Austria, Austria, 3100
        • Landesklinikum St. Pölten
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • Landesklinikum Wiener Neustadt
    • Tirol
      • Innsbruck, Tirol, Austria
        • Medical University Innsbruck
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria
        • Landesklinikum Feldkirch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological verification of esophageal cancer
  • Presence of T2,T3,T4 or any N1 (except M1)
  • Clinically measurable lesions according to RECIST criteria
  • Males and females, age >18 to 75 or older with WHO performance status 1
  • No prior tumor therapy for esophageal cancer
  • No other malignancy in history within 5 years before evaluation
  • Performance status of 0-2 on ECOG scale
  • Medical fitness (adequate for possible esophageal resection, adequate organ function: see protocol)
  • Signed informed consent
  • Males and females with reproductive potential must use an approved contraceptive method. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

  • Inoperability (technical or functional)
  • Clinical stage cT1N0, any M1
  • Treatment with any of the investigational drugs within the last 6 months
  • Concurrent administration of any other tumor therapy
  • Pregnancy, breast feeding
  • Serious concomitant disorders that would compromise the safety of the patient or ability to complete the study
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: 5-Fluoruracil, Cisplatinum

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

Cisplatin 80mg/m2; day 1; 3 cycles: q21
Experimental: B
Drug: Docetaxel
Docetaxel 75mg/m2, day 1; 3 cycles; q21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete pathological response and relation to p53 genotype
Time Frame: 12 weeks
12 weeks
Complete tumor resection rate
Time Frame: 12 weeks
12 weeks
Perioperative morbidity and mortality
Time Frame: 16 weeks
16 weeks
Disease free and overall survival and relation to p53 genotype
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Kandioler

Collaborators

Medical University of Vienna
Austrian Society Of Surgical Oncology

Investigators

  • Study Chair: Daniela Kandioler, Prof., MBA, ASSO Representative, MUW, p53research Head
  • Study Director: Johannes Zacherl, Prof., Medical University of Vienna, MUV
  • Study Director: Michael Hejna, Prof., MUW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Kandioler D et al. p53 adapted neoadjuvant therapy for esophageal cancer: pilot study. JCO, vol 25, 18S: 206s

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASSO OE-1
  • EudraCT 2006-006647-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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