p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniela Kandioler
• Collaborators: Austrian Society Of Surgical Oncology; Medical University of Vienna
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

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