p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

NCT00525200 | Completed Phase 3 DMC

• 2 other identifiers: ASSO OE-1EudraCT 2006-006647-31
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 13

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.

Conditions

Esophageal Cancer

Keywords

predictive marker; personalized therapy; response assessment; p53 genotype

Outcome Measures

Primary Outcomes (1)

• Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype

  12 weeks

Secondary Outcomes (4)

• Complete pathological response and relation to p53 genotype

  12 weeks

• Complete tumor resection rate

  12 weeks

• Perioperative morbidity and mortality

  16 weeks

• Disease free and overall survival and relation to p53 genotype

  2 years

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: 5-Fluoruracil, Cisplatinum

B

EXPERIMENTAL

Drug: Docetaxel

Interventions

5-Fluoruracil, Cisplatinum DRUG

5 FU 1000mg/m2; days 1-5; 3 cycles: q21 Cisplatin 80mg/m2; day 1; 3 cycles: q21

A

Docetaxel DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniela Kandioler: lead
• Medical University of Vienna: collaborator
• Austrian Society Of Surgical Oncology: collaborator

Study Sites (13)

Landesklinikum St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Location

Rudolfstiftung

Vienna, Vienna, 1030, Austria

Location

SMZ OST

Vienna, Vienna, Austria

Location

Wilhelminenspital

Vienna, Vienna, Austria

Location

Landesklinikum Feldkirch

Feldkirch, Vorarlberg, Austria

Location

Landeskrankenhaus Leoben

Leoben, 8790, Austria

Location

Krankenhaus der Elisabethinen

Linz, 4020, Austria

Location

Krankenhaus der Barmherzigen Brüder

Stankt Veit, 9300, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Kaiser Franz Josef Spital

Vienna, 1100, Austria

Location

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

Related Publications (1)

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

  BACKGROUND

Related Links

• p53research group at the University of Vienna

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Daniela Kandioler, Prof., MBA

  ASSO Representative, MUW, p53research Head

  STUDY CHAIR

• Johannes Zacherl, Prof.

  Medical University of Vienna, MUV

  STUDY DIRECTOR

• Michael Hejna, Prof.

  MUW

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ. Prof. Dr., MBA

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

AU (13)