irinotecan-based triplet (folfoxiri) as perioperative treatment in resectable gastric and gastroesophageal junction adenocarcinoma.

Conditions: Resectable Gastric and Gastroesophageal Junction Adenocarcinoma

Summary: in this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma will be included. treatment with curative intent will be given with chemotherapy for 4 cycles with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then additionally 4 cycles of the same chemotherapy postoperatively. the standard treatment today is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. the rationale for this trial is, that the addition of irinotecan might improve treatments results.


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

Keywords: gastric adenocarcinoma gastroesophageal junction adenocarcinoma chemotherapy fluorouracil oxaliplatin irinotecan preoperative chemotherapy postoperative chemotherapy histopathological response rate of r0-resection