limited-metastatic adenocarcinoma of the stomach or esophagogastric junction
Conditions
Sponsors
Krankenhaus Nordwest gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed limited metastatic gastric or GEJ adenocarcinoma.* 2.Medical and technical operability of the primary. 3.Metastatic lesions are resectable or can be controlled by local ablative procedure (central evaluation). 4.No prior chemotherapy and no prior tumor resection. 5.Female and male patients >18 years. Patients in reproductive age must be willing to use adequate contraception during the study and 3 months after the end of the study (Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start. 6.ECOG 0 or 1 7.Adequate hematological, hepatic and renal function parameters: -Leukocytes = 3000/µl -Platelets = 100,000/µl -Serum creatinine = 1.5 x upper limit of normal, or GFR > 40 ml/min -Bilirubin = 1.5 x upper limit of normal -AST and ALT = 3.5 x upper limit of normal -Alkaline phosphatase = 6 x upper limit of normal 8.Written informed consent of the patient. (*) Definition of the limited metastatic status according Flot3-study with modification is: 1.Retroperitoneal lymph node metastases (RPLM) (e.g., para-aortal, intra-aorto-caval, parapancreatic or mesenterial lymph nodes) only or/and 2.at maximum one organ involved with or without RPLM according to the following schema: I.Localized potentially operable peritoneal carcinomatosis: stage P1 according to classification of the „Japanese Research Society for Gastric Cancer“ (Clinically visible carcinomatosis of the peritoneum or of the pleura and >P1 peritoneal carcinomatosis are not allowed!) or II.Liver: maximum of 5 metastatic lesions that are potentially resectable or III.Lung: unilateral involvement, potentially resectable or IV.Uni- or bilateral Krukenberg tumors (ovarian met.) in the absence of macroscopic peritoneal carcinomatosis or V.Uni- or bilateral adrenal gland metastases or VI.Extra-abdominal lymph node metastases such as supraclavicular lymph node involvement or VII.Localized bone involvement (defined as being within one radiation field) or VIII.Other metastatic disease location that is considered limited by the investigator and is confirmed by the review committee 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 271 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 271
Exclusion criteria
Exclusion criteria: 1.Medical inoperability 2.Inability to understand the aims of the study and/or protocol procedures 3.Metastatic disease not fulfilling the criteria of limited disease mentioned in the inclusion criteria or non-metastatic stage (cM0) 4.Cirrhosis of the liver, pronounced alcohol abuse with anticipated detoxification, severe pulmonary infection with considerable reduction of pulmonary function 5.Primary not resectable 6. Hypersensitivity to 5-fluorouracil, leucovorin, oxaliplatin, or docetaxel 7. Contraindication versus 5-fluorouracil, leucovorin, oxaliplatin, or docetaxel (see specific product information) 8.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV 9.Clinically significant valvular defect 10.Past or current history of other malignancies unless curatively treated and without evidence of disease for more than 3 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 11.Known brain metastases 12.Other severe internal disease or acute infection 13.Peripheral polyneuropathy > NCI grade II 14.Serious hepatic impairment (AST/ALT>3.5xULN, AP>6xULN, bilirubin>1.5xULN) 15.Chronic inflammatory bowel disease 16.Any other concurrent antineoplastic treatment including irradiation 17.Participation in another clinical study 18.Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall survival (OS) (The duration of OS will be determined by measuring the time interval from randomization to the date of death or last observation (censored));Secondary Objective: •Quality of life (QoL) adjusted OS •QoL-response •QoL mean scores •OS in patients with lymph node metastases only •Progression free survival (PFS): time interval from randomization until disease progression or disease recurrence after surgery or death of any cause •Surgical morbidity and mortality •Toxicity ;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Quality of life (QoL) adjusted OS •QoL-response •QoL mean scores •OS in patients with lymph node metastases only •Progression free survival (PFS): time interval from randomization until disease progression or disease recurrence after surgery or death of any cause •Surgical morbidity and mortality;Timepoint(s) of evaluation of this end point: •Quality of life (QoL) adjusted OS - continuously •QoL-response - continuously •QoL mean scores - end of study •OS in patients with lymph node metastases only - continuously •Progression free survival (PFS) - continuously •Surgical morbidity and mortality - after surgery | — |
Countries
Germany
Contacts
Public ContactIKF
Institut für Klinisch-Onkologische Forschung, Krankenhaus Nordwest gGmbH
Outcome results
None listed