locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Masaryk Memorial Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of 18 years or more 2. Not currently participating in another study 3. Able and willing to sign informed consent and to comply with study procedures 4. Biopsy-proven locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc I. Adenocarcinoma of distal part of the oesophagus II. Adenocarcinoma of the real cardia III. Adenocarcinoma of the subcardial stomach 5. Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET 6. Eligible patients have to be fit for platinum-containing chemotherapy 7. Tumours must be potentially R0 resectable tumours during consecutive operation. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial of a therapeutic drug during the past 14 days 2. Addiction to alcohol or drugs 3. Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative blood pregnancy test before enrollment 4. Pregnant women and nursing mothers are not allowed to enroll on this study 5. Eastern Cooperative Oncology Group score >2 6. Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma) 7. Life expectancy of less than 3 months 8. Uncontrolled bleeding from the tumour 9. Uncontrolled diabetes 10. Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the FDG-PET dynamics predictive value from comparison of scans acquired (i) before initiation of preoperative chemotherapy and (ii) after first cycle of chemotherapy, through correlation of PET-based early regression with R0 resection rate. ;Secondary Objective: 1) Identification of tissue/plasma miRNAs enabling to stratify OGC patients accordingly to FDG-PET positivity. 2) Identification of tissue/plasma miRNA panels enabling prediction of response to preoperative chemotherapy (based on TRG) through genome-wide miRNA expression profiling of biopsies/plasma samples collected (i) before initiation of the treatment and (ii) by evaluation of miRNA profiles dynamics after 14 days of the treatment. 3) Evaluation of circulating immune cells, circulating antibody profile, tumour-bound profile in the context of FDG-PET positivity and response to chemotherapy and chemoradiotherapy, respectively. 4) PET predictive value for DFS and OS ;Primary end point(s): R0 resection rate in arm B (metabolic non-responders);Timepoint(s) of evaluation of this end point: After surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease free survival in arm A and arm B Overall survival in arm A and arm B ;Timepoint(s) of evaluation of this end point: 5 years 5 years | — |
Countries
Czech Republic, Slovakia
Contacts
Public ContactClinical trials unit
Masaryk Memorial Cancer Institute
Outcome results
None listed