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

This study has been completed.
Sponsor:
Collaborators:
Medical University of Vienna
Austrian Society Of Surgical Oncology
Information provided by (Responsible Party):
Daniela Kandioler, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00525200
First received: September 4, 2007
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Esophageal Cancer
Drug: 5-Fluoruracil, Cisplatinum
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete pathological response and relation to p53 genotype [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Complete tumor resection rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Perioperative morbidity and mortality [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Disease free and overall survival and relation to p53 genotype [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 170
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525200

Locations
Austria
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
Hanusch Krankenhaus
Vienna, Austria, 1140
Kaiser Franz Josef Spital
Vienna, Austria, 1100
Medical University of Vienna
Vienna, Austria, 1090
Rudolfstiftung
Vienna, Austria, 1030
SMZ OST
Vienna, Austria
Wilhelminenspital
Vienna, Austria
Sponsors and Collaborators
Daniela Kandioler
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
  More Information

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

Responsible Party: Daniela Kandioler, Univ. Prof. Dr., MBA, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00525200     History of Changes
Other Study ID Numbers: ASSO OE-1, EudraCT 2006-006647-31
Study First Received: September 4, 2007
Last Updated: December 20, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
predictive marker
personalized therapy
response assessment
p53 genotype

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014