adenocarcinoma of the esophagus and esophago-gastric junction
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cisplatin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: epirubicin
Pharm
Sponsors
The Motol University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age 18-75 years, males and females histologically verified adenocarcinoma of the esophagus or esophago-gastric junction or proximal stomach affecting cardia no distant metastases or non-regional lymph node metastasis on computed tomography of chest and abdomen cT1, N1, M0-1a or cT2-T4 (potentially resectable tumor), N0-1, M0-1a (TNM staging AJCC 6th edition) on EUS and CT performance status 0-1 (WHO) medically fit for elective esophagectomy after neoadjuvant chemotherapy signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Patients with insulin-dependent diabetes mellitus or DM II on oral antidiabetics with glycemia level above 10 mmol/l Patients with the finding of distant organ metastases at the inicial FDG-PET/CT will be excluded from the study pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of this project is to prove hypothesis that the metabolic-anatomic information gained from FDG-PET/CT examination may be used for early identification of responders to neoadjuvant chemotherapy in already 14 days after the beginning of the treatment. The specific immediate objectives of the project: · Investigate if there is a correlation between the decrease of tumor metabolic activity (expressed as the decrease of consumption of glucose in FDG-PET/CT examination) 2 weeks after the start of neoadjuvant chemotherapy and 4 weeks after the completion of neoadjuvant chemotherapy and the rate of histopathologic regression of the tumor in the specimen after surgical resection. · In the case of proven correlation establish a threshold value of decrease of metabolic activity (assessed by quantitative PERCIST 1.0 criteria) which, with sufficient reliability, would differentiate responders from non-responders 14 days after the start of neoadjuvant chemotherapy ;Secondary Objective: · Investigate whether the level of metabolic activity of the tumor (as assessed qualitatively and quantitatively by PERCIST 1.0 criteria) 4 weeks after completion of neoadjuvant therapy correlates with the histopathological tumor regression · Validate parameters of complete and partial metabolic response as recommended by PERCIST 1.0 in the case of neoadjuvant chemotherapy for adenocarcinoma of the esophagus and esophago-gastric junction with regard to histopathologic response · Compare parameters SULpeak, SULpixel, TLG in terms of their reliability to predict histopathologic response on FDG-PET / CT examination 14 days after the start and 4 weeks after the completion of neoadjuvant chemotherapy ;Primary end point(s): to establish a threshold value of the decrease (%) of SULpeak, SULpixel, TLG and SUVavg of the tumor on FDG-PET/CT examination (assessed by quantitative PERCIST 1.0 criteria) 14 days after the start of neoadjuvant chemotherapy which, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to find out which parameter of metabolic activity on FDG-PET/CT (SULpeak, SULpixel, TLG, SUVavg) has the highest sensitivity and specificity in identifying responders to neoadjuvant chemotherapy;Timepoint(s) of evaluation of this end point: patients accrual from 2011 to 2014 data analysis in 2015 | — |
Countries
Czech Republic
Contacts
Public ContactTomáš Haruštiak, MD
The Motol University Hospital
Outcome results
None listed