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


Phase 3
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Daniela Kandioler, Prof., MBA

Investigator Role:

Study Chair

Investigator Affiliation:

ASSO Representative, MUW, p53research Head

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

ASSO OE-1

NCT ID:

NCT00525200

Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Esophageal Cancer
  • predictive marker
  • personalized therapy
  • response assessment
  • p53 genotype
  • Esophageal Diseases
  • Esophageal Neoplasms

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