Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT02578368
Eligibility 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: intrauterine device, 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 (Eastern Cooperative Oncology Group) Performance Status 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 glomerular filtration rate (GFR) \> 40 ml/min
* Bilirubin ≤ 1.5 x upper limit of normal
* AST (aspartate aminotransferase) and ALT (alanine transaminase) ≤ 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 is:
1. Retroperitoneal lymph node metastases (RPLM) (e.g., para-aortal, intra-aorto-caval, parapancreatic or mesenterial lymph nodes) only (Note: in duodenum invading gastric cancer, retropancreatic nodes are not regarded M1) 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 or cervical 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
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 (New York Heart Association) 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; ULN = upper limit of normal)
15. Chronic inflammatory bowel disease
16. Any other concurrent antineoplastic treatment including irradiation
17. Participation in another clinical study
18. Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02578368
Study Brief:
Protocol Section:
NCT02578368