The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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