p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer - Full Text View

Sponsor:	Daniela Kandioler
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

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 III

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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

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 ]

Estimated Enrollment:	170
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	March 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

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

Contacts

Contact: Daniela Kandioler, Prof., MBA

43-14-0400 ext 5447

Daniela.Kandioler@meduniwien.ac.at

Locations

Austria
Landesklinikum St. Pölten	Recruiting
St. Polten, Lower Austria, Austria, 3100
Contact: Ronald Zwrtek, MD, MAS office@zwrtek.at
Sub-Investigator: Michael Pober, MD
Principal Investigator: Ronald Zwrtek, MD, MAS
Landesklinikum Wiener Neustadt	Recruiting
Wiener Neustadt, Lower Austria, Austria, 2700
Contact: Friedrich Laengle, Prof. friedrich.laengle@kh-wrn.ac.at
Principal Investigator: Friedrich Laengle, Prof.
Sub-Investigator: Istvan Viragos-Toth, MD
Medical University Innsbruck	Recruiting
Innsbruck, Tirol, Austria
Contact: Dietmar Oefner, Prof Dietmar.oefner@i-med.ac.at
Principal Investigator: Dietmar Oefner, Prof
Landesklinikum Feldkirch	Recruiting
Feldkirch, Vorarlberg, Austria
Contact: Etienne Wenzl, rof etienne.wenzl@lkhf.at
Sub-Investigator: Michael Knauer, MD
Landeskrankenhaus Leoben	Recruiting
Leoben, Austria, 8790
Contact: Felix Keil, Prof. felix.keil@lkh-leoben.at
Principal Investigator: Felix Keil, Prof.
Sub-Investigator: Uwe Kastner, MD
Krankenhaus der Elisabethinen	Recruiting
Linz, Austria, 4020
Contact: Reinhold Fuegger, Prof. reinhold.fuegger@elisabethinen.or.at
Principal Investigator: Reinhold Fuegger, Prof.
Sub-Investigator: Florian Tomaselli, MD
Krankenhaus der Barmherzigen Brüder	Recruiting
Stankt Veit, Austria, 9300
Contact: Jörg Tschmelitsch, Prof. joerg.tschmelitsch@bbstveit.at
Principal Investigator: Jörg Tschmelitsch, Prof.
Sub-Investigator: Harald Weiss, MD
Kaiser Franz Josef Spital	Recruiting
Vienna, Austria, 1100
Contact: Josef Karner, Prof. josef.karner@wienkav.at
Principal Investigator: Josef Karner, Prof.
Sub-Investigator: Sabine Thalhammer
Hanusch Krankenhaus	Recruiting
Vienna, Austria, 1140
Contact: Michael Hold, Prof. michael.hold@wgkk.sozvers.at
Principal Investigator: Michael Hold, Prof.
Sub-Investigator: Marianne Bernhard, MD
Sub-Investigator: Christian Österreicher, MD
Rudolfstiftung	Recruiting
Vienna, Austria, 1030
Contact: Rudolf Roka, MD, Prof. 003 1 711 65 ext 4101 rudolf.roka@wienkav.at
Principal Investigator: Rudolf Roka, MD, Prof.
Medical University of Vienna	Recruiting
Vienna, Austria, 1090
Contact: Daniela Kandioler, Prof.,MBA 43-14-0400 ext 6939 Daniela.Kandioler@meduniwien.ac.at
Principal Investigator: Johannes Zacherl, MD, Prof.
Principal Investigator: Michael Hejna, MD, Prof.
Sub-Investigator: Walter Klepetko, MD, Prof.
Sub-Investigator: Gerhard Prager, MD, Prof.
Sub-Investigator: Martin Riegler, MD, Prof.
Sub-Investigator: Irene Kuehrer, MD, Prof.
Sub-Investigator: Sebastian F Schoppmann, MD, Prof
SMZ OST	Not yet recruiting
Vienna, Austria
Contact: Nikolaus Hölbling, MD nikolaus.hölbling@wienkav.at
Wilhelminenspital	Recruiting
Vienna, Austria
Contact: Karl Glaser, Prof karl.glaser@wienkav.at
Sub-Investigator: Rene Fortelny, MD

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:

p53research group at the University of Vienna This link exits the ClinicalTrials.gov site

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:	November 11, 2011
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 Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Head and Neck Neoplasms
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012