p53-Adjusted Neoadjuvant Chemotherapy for potentially resectable Oesophageal Cancer pANCHO. - pANCHO

Active, not recruiting

• Conditions: Interaction between a predictive marker and response to induction chemotherapy in patients with potentially resectable esophageal cancerPredictive Marker Trial; MedDRA version: 9.1Level: LLTClassification code 10015362Term: Esophageal cancer

• Registration Number: EUCTR2006-006647-31-AT
• Lead Sponsor: The Austrian Society of Surgical Oncology (ACO-ASSO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

- Histological verification of esophageal cancer (any subtype)
- Presence of T2, T3, T4 or any N1 disease except patients with distant metastasis (M1)
(potentially resectable)
- No prior tumor therapy for esophageal cancer
- Performance status of 0-2 on ECOG scale
- Medical fitness of patient, including respiratory function, adequate for possible radical
esophageal resection.
- Males and females, age >18 to 75 years or elder patients with WHO performance
status 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Inoperability (technical or functional)
- Clinical stage cT1N0
- Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic
chemotherapy, immunotherapy, molecular target therapy, genetherapy.
- Second primary malignancy that is clinically detectable at the time of consideration for
study enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): is response to neoadjuvant treatment;Main Objective: The objective of this prospective randomized predictive marker study is to evaluate the interaction between a predictive marker and response to induction chemotherapy in patients with potentially resectable esophageal cancer.<br>This study is designed to demonstrate the significant interaction of the two p53 genotypes (mutant versus normal) and response to 2 different neoadjuvant chemotherapies.<br>;Secondary Objective: •Evaluation of the complete pathohistological response rates<br><br>•Evaluation of the disease free survival and overall survival after neoadjuvant therapy<br><br>•Evaluation of the complete tumor resection rate after neoadjuvant therapy <br><br>•Evaluation of perioperative morbiditiy and mortality after neoadjuvant therapy<br><br>All calculations will consider the relation between the secondary endpoints and the predictive marker status and to the type of chemotherapy.<br><br>