p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer (PANCHO)

This study has been completed.
Sponsor:
Collaborators:
Medical University of Vienna
Austrian Society Of Surgical Oncology
Information provided by (Responsible Party):
Daniela Kandioler, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00525200
First received: September 4, 2007
Last updated: December 20, 2012
Last verified: December 2012

September 4, 2007
December 20, 2012
June 2007
May 2012   (final data collection date for primary outcome measure)
Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00525200 on ClinicalTrials.gov Archive Site
  • Complete pathological response and relation to p53 genotype [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Complete tumor resection rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Perioperative morbidity and mortality [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Disease free and overall survival and relation to p53 genotype [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Complete pathological response and relation to p53 genotype [ Time Frame: 12 weeks ]
  • Complete tumor resection rate [ Time Frame: 12 weeks ]
  • Perioperative morbidity and mortality [ Time Frame: 16 weeks ]
  • Disease free and overall survival and relation to p53 genotype [ Time Frame: 2 years ]
Not Provided
Not Provided
 
p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer
p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Esophageal Cancer
  • Drug: 5-Fluoruracil, Cisplatinum

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

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

  • Drug: Docetaxel
    Docetaxel 75mg/m2, day 1; 3 cycles; q21
  • Active Comparator: A
    Intervention: Drug: 5-Fluoruracil, Cisplatinum
  • Experimental: B
    Intervention: Drug: Docetaxel
Kandioler D et al. p53 adapted neoadjuvant therapy for esophageal cancer: pilot study. JCO, vol 25, 18S: 206s

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
December 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00525200
ASSO OE-1, EudraCT 2006-006647-31
Yes
Daniela Kandioler, Medical University of Vienna
Daniela Kandioler
  • Medical University of Vienna
  • Austrian Society Of Surgical Oncology
Study Chair: Daniela Kandioler, Prof., MBA ASSO Representative, MUW, p53research Head
Study Director: Johannes Zacherl, Prof. Medical University of Vienna, MUV
Study Director: Michael Hejna, Prof. MUW
Medical University of Vienna
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP