Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.

• Status: Recruiting
• Trial end date: 2026-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Oxaliplatin

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