Histologically confirmed adenocarcinoma of the oesophagogastric junction (AEG) (ICD-classification: C15.5 / C16.0) MedDRA version: 20.0 Level: LLT Classification code 10018017 Term: Gastrointestinal tract cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/m2 milligram(s)/square meter
Sponsors
Technische Universität München Fakultaet fuer Medizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed AEG I-III • Potentially R0 - resectable AEG and primary tumor category UT2 -4 • Functional operability: Exclusion of OP - limiting comorbidities • Intense FDG tracer uptake of the tumor during Baseline PET/CT-) and thus suitability for monitoring and early response prediction by FDG - PET ( [ 18F ] - FDG uptake in the tumor at baseline > 1.35 x liver SUV + 2 x standard deviation of the liver SUV) • Performance status (ECOG ) 0 or 1 • Age : = 18 • creatinine clearance > 60ml/min, measured or calculated • bilirubin = 1.5 times upper limit of normal , serum transaminases (GOT / GPT ) = 3 times ULN • leukocytes = 3.5 g / l, platelet = 100 g / l • Negative pregnancy test (determination of beta- HCG in urine or serum) in women of childbearing potential • A signed consent form after implementation of medical education 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Existing distant metastases (M1b) • Tumor infiltration into the tracheobronchial system • Previous radiotherapy targeted at the thorax • Lack of ability of the patient to adhere to the protocol rules • Manifested heart failure despite of optimal medication> NYHA I • existing angina pectoris at rest or undergoing stress without clarification via interventional cardiology and / or myocardial infarction within the last 6 months • Existing pregnancy or lactation • childbearing or fertility without using recognized safe methods of contraception • Coexisting other malignant diseases with the exception of non- melanomatuous, localized skin tumor or carcinoma in situ of the cervix • absence of a signed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: R0 resection rate of patients suffering from metabolically (following PET criteria) chemotherapy-resistant, locally advanced AEG, who receive a more intensive neoadjuvant radio-chemotherapy (INRCT);Secondary Objective: •Histological regression defined by Becker Criteria •Overall survival defined as period from start of study to death (if necessary censored by end of follow-up period) •Disease-free survival, defined as period from start of study to earlier occurring event: death or relapse until end of follow-up; Relapse will be separated into events of "local failure", "distant failure" and "local and distant failure" •Quality of life, analyzed via EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires •Metabolic response rate under neoadjuvant chemotherapy •Translational analysis for identification of tumor determinants relevant for prognosis and therapy ;Primary end point(s): R0 resection rate of patients suffering from metabolically (following PET criteria) chemotherapy-resistant, locally advanced AEG, who receive a more intensive neoadjuvant radio-chemotherapy (INRCT);Timepoint(s) of evaluation of this end point: R0 resection rate [ Time Frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: •Regression [ Time Frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy) ] •Overall survival [ Time Frame: from day 0 to follow up visit 6 (24 months after surgery) ] •Disease-free survival [ Time Frame: from day 0 to follow up visit 6 (24 months after surgery) ] •Quality of life [ Time Frame: from day 0 to follow up visit 6 (24 months after surgery) ] •Metabilic response rate [ Time Frame: from day 0 to one time point of time period day 14 to 28 after chemotherapy ] •Translational analysis [ Time Frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy) ] ;Secondary end point(s): •Histological regression defined by Becker Criteria •Overall survival defined as period from start of study to death (if necessary censored by end of follow-up period) •Disease-free survival, defined as period from start of study to earlier occurring event: death or relapse until end of follow-up; Relapse will be separated into events of "local failure", "distant failure" and "local and distant failure" •Quality of life, analyzed via EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires •Metabolic response rate under neoadjuvant chemotherapy •Translational analysis for identification of tumor determinants relevant for prognosis and therapy | — |
Countries
Germany
Contacts
Public ContactDr. rer. nat. Christian Schläger
Münchner Studienzentrum
Outcome results
None listed