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Spots Global Cancer Trial Database for p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

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Trial Identification

Brief Title: p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

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

Study ID: NCT00525200

Study Description

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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Landesklinikum St. Pölten, St. Polten, Lower Austria, Austria

Landesklinikum Wiener Neustadt, Wiener Neustadt, Lower Austria, Austria

Medical University Innsbruck, Innsbruck, Tirol, Austria

Landesklinikum Feldkirch, Feldkirch, Vorarlberg, Austria

Landeskrankenhaus Leoben, Leoben, , Austria

Krankenhaus der Elisabethinen, Linz, , Austria

Krankenhaus der Barmherzigen Brüder, Stankt Veit, , Austria

Rudolfstiftung, Vienna, , Austria

Medical University of Vienna, Vienna, , Austria

Kaiser Franz Josef Spital, Vienna, , Austria

Hanusch Krankenhaus, Vienna, , Austria

SMZ OST, Vienna, , Austria

Wilhelminenspital, Vienna, , Austria

Contact Details

Name: Daniela Kandioler, Prof., MBA

Affiliation: ASSO Representative, MUW, p53research Head

Role: STUDY_CHAIR

Name: Johannes Zacherl, Prof.

Affiliation: Medical University of Vienna, MUV

Role: STUDY_DIRECTOR

Name: Michael Hejna, Prof.

Affiliation: MUW

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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