p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

NCT ID: NCT00525200

Last Updated: 2012-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Esophageal Cancer

Keywords

predictive marker; personalized therapy; response assessment; p53 genotype

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

5-Fluoruracil, Cisplatinum

Intervention Type: DRUG

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

Cisplatin 80mg/m2; day 1; 3 cycles: q21

B

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel 75mg/m2, day 1; 3 cycles; q21

Interventions

5-Fluoruracil, Cisplatinum

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

Cisplatin 80mg/m2; day 1; 3 cycles: q21

Intervention Type: DRUG

Docetaxel

Docetaxel 75mg/m2, day 1; 3 cycles; q21

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

Austrian Society Of Surgical Oncology

OTHER

Sponsor Role: collaborator

Daniela Kandioler

OTHER

Sponsor Role: lead

Responsible Party

Daniela Kandioler

Univ. Prof. Dr., MBA

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniela Kandioler, Prof., MBA

Role: STUDY_CHAIR

ASSO Representative, MUW, p53research Head

Johannes Zacherl, Prof.

Role: STUDY_DIRECTOR

Medical University of Vienna, MUV

Michael Hejna, Prof.

Role: STUDY_DIRECTOR

MUW

Locations

Landesklinikum St. Pölten

Sankt Pölten, Lower Austria, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Rudolfstiftung

Vienna, Vienna, Austria

SMZ OST

Vienna, Vienna, Austria

Wilhelminenspital

Vienna, Vienna, Austria

Landesklinikum Feldkirch

Feldkirch, Vorarlberg, Austria

Landeskrankenhaus Leoben

Leoben, , Austria

Krankenhaus der Elisabethinen

Linz, , Austria

Krankenhaus der Barmherzigen Brüder

Stankt Veit, , Austria

Medical University of Vienna

Vienna, , Austria

Kaiser Franz Josef Spital

Vienna, , Austria

Hanusch Krankenhaus

Vienna, , Austria

Countries

Austria

References

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

Reference Type: BACKGROUND

Related Links

http://www.p53.at

p53research group at the University of Vienna

Other Identifiers

EudraCT 2006-006647-31

Identifier Type: -

Identifier Source: secondary_id

ASSO OE-1

Identifier Type: -

Identifier Source: org_study_id