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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. Identifier: NCT00525200
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : December 21, 2012
Medical University of Vienna
Austrian Society Of Surgical Oncology
Information provided by (Responsible Party):
Daniela Kandioler, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: 5-Fluoruracil, Cisplatinum Drug: Docetaxel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial
Study Start Date : June 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

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

Primary Outcome Measures :
  1. Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Complete pathological response and relation to p53 genotype [ Time Frame: 12 weeks ]
  2. Complete tumor resection rate [ Time Frame: 12 weeks ]
  3. Perioperative morbidity and mortality [ Time Frame: 16 weeks ]
  4. Disease free and overall survival and relation to p53 genotype [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525200

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Landesklinikum St. Pölten
St. Polten, Lower Austria, Austria, 3100
Landesklinikum Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Medical University Innsbruck
Innsbruck, Tirol, Austria
Landesklinikum Feldkirch
Feldkirch, Vorarlberg, Austria
Landeskrankenhaus Leoben
Leoben, Austria, 8790
Krankenhaus der Elisabethinen
Linz, Austria, 4020
Krankenhaus der Barmherzigen Brüder
Stankt Veit, Austria, 9300
Vienna, Austria, 1030
Medical University of Vienna
Vienna, Austria, 1090
Kaiser Franz Josef Spital
Vienna, Austria, 1100
Hanusch Krankenhaus
Vienna, Austria, 1140
Vienna, Austria
Vienna, Austria
Sponsors and Collaborators
Daniela Kandioler
Medical University of Vienna
Austrian Society Of Surgical Oncology
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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
Additional Information:
Kandioler D et al. p53 adapted neoadjuvant therapy for esophageal cancer: pilot study. JCO, vol 25, 18S: 206s

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Responsible Party: Daniela Kandioler, Univ. Prof. Dr., MBA, Medical University of Vienna Identifier: NCT00525200    
Other Study ID Numbers: ASSO OE-1
EudraCT 2006-006647-31
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Keywords provided by Daniela Kandioler, Medical University of Vienna:
predictive marker
personalized therapy
response assessment
p53 genotype
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs