Interaction between a predictive marker and response to induction chemotherapy in patients with potentially resectable esophageal cancer Predictive Marker Trial MedDRA version: 9.1 Level: LLT Classification code 10015362 Term: Esophageal cancer
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663271
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
The Austrian Society of Surgical Oncology (ACO-ASSO)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. This study is designed to demonstrate the significant interaction of the two p53 genotypes (mutant versus normal) and response to 2 different neoadjuvant chemotherapies. ;Secondary Objective: •Evaluation of the complete pathohistological response rates •Evaluation of the disease free survival and overall survival after neoadjuvant therapy •Evaluation of the complete tumor resection rate after neoadjuvant therapy •Evaluation of perioperative morbiditiy and mortality after neoadjuvant therapy All calculations will consider the relation between the secondary endpoints and the predictive marker status and to the type of chemotherapy. ;Primary end point(s): is response to neoadjuvant treatment | — |
Countries
Austria
Outcome results
None listed