p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

Esophageal Cancer Clinical Trial

— PANCHO  

Official title:

p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525200
• Other study ID #: ASSO OE-1
• Secondary ID: EudraCT 2006-006
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2007
• Last updated: December 20, 2012
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• 5-Fluoruracil, Cisplatinum
5 FU 1000mg/m2; days 1-5; 3 cycles: q21 Cisplatin 80mg/m2; day 1; 3 cycles: q21
• Docetaxel
Docetaxel 75mg/m2, day 1; 3 cycles; q21

Locations

Country	Name	City	State
Austria	Landesklinikum Feldkirch	Feldkirch	Vorarlberg
Austria	Medical University Innsbruck	Innsbruck	Tirol
Austria	Landeskrankenhaus Leoben	Leoben
Austria	Krankenhaus der Elisabethinen	Linz
Austria	Landesklinikum St. Pölten	St. Polten	Lower Austria
Austria	Krankenhaus der Barmherzigen Brüder	Stankt Veit
Austria	Hanusch Krankenhaus	Vienna
Austria	Kaiser Franz Josef Spital	Vienna
Austria	Medical University of Vienna	Vienna
Austria	Rudolfstiftung	Vienna
Austria	SMZ OST	Vienna
Austria	Wilhelminenspital	Vienna
Austria	Landesklinikum Wiener Neustadt	Wiener Neustadt	Lower Austria

Sponsors (3)

Lead Sponsor	Collaborator
Daniela Kandioler	Austrian Society Of Surgical Oncology, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype		12 weeks	Yes
Secondary	Complete pathological response and relation to p53 genotype		12 weeks	Yes
Secondary	Complete tumor resection rate		12 weeks	Yes
Secondary	Perioperative morbidity and mortality		16 weeks	Yes
Secondary	Disease free and overall survival and relation to p53 genotype		2 years	Yes

External Links

•   p53research group at the University of Vienna