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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


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
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