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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525200
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : December 21, 2012
Sponsor:
Collaborators:
Medical University of Vienna
Austrian Society Of Surgical Oncology
Information provided by (Responsible Party):
Daniela Kandioler, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE September 4, 2007
First Posted Date  ICMJE September 5, 2007
Last Update Posted Date December 21, 2012
Study Start Date  ICMJE June 2007
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
  • Complete pathological response and relation to p53 genotype [ Time Frame: 12 weeks ]
  • Complete tumor resection rate [ Time Frame: 12 weeks ]
  • Perioperative morbidity and mortality [ Time Frame: 16 weeks ]
  • Disease free and overall survival and relation to p53 genotype [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer
Official Title  ICMJE p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: 5-Fluoruracil, Cisplatinum
  • Experimental: B
    Intervention: Drug: Docetaxel
Publications * Kandioler D et al. p53 adapted neoadjuvant therapy for esophageal cancer: pilot study. JCO, vol 25, 18S: 206s

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2011)
170
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2007)
84
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525200
Other Study ID Numbers  ICMJE ASSO OE-1
EudraCT 2006-006647-31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniela Kandioler, Medical University of Vienna
Study Sponsor  ICMJE Daniela Kandioler
Collaborators  ICMJE
  • Medical University of Vienna
  • Austrian Society Of Surgical Oncology
Investigators  ICMJE
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
PRS Account Medical University of Vienna
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP