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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03773367
Eligibility Criteria:
Inclusion Criteria:
* Histologically verified, resectable gastric or gastroesophageal (GE) (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of patient operability by surgeon
* Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0
* Age: 18 years or older
* World Health Organization (WHO) performance status ≤ 1
* Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
* Adequate laboratory findings:
* hematological: hemoglobin \> 90 g/L (transfusion is allowed to attain this), absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L
* hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 3 x ULN
* renal: creatinine ≤ 1.5 x ULN (upper limit of normal)
* Fertile men and women must use highly effective means of contraception (failure rate \<1%) such as:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration)
* progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration)
* intrauterine device
* intrauterine hormone-releasing system
* bilateral tubal occlusion
* vasectomised partner
* sexual abstinence
* Signed written informed consent
* The patient must be able to comply with the protocol
Exclusion Criteria:
* Neuroendocrine or adenosquamous carcinoma
* Prior oncological treatment or surgical resection for the present disease
* Presence of other concurrent malignancies or previous malignancies within 5 years except for adequately treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix uteri
* Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
* Active inflammatory bowel disease
* Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
* Known hypersensitivity to any contents of the study drugs
* Pregnancy (positive pregnancy test) and/or breast feeding
* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03773367
Study Brief:
Protocol Section:
NCT03773367