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NCT03773367Active, not recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
10 Dec 2018
Start date
14 Dec 2018
Primary completion date
30 Nov 2026
Lead sponsor
Lund University Hospital
NCT number
NCT03773367
EU CT number
2023-509044-96-00
EudraCT number
2018-000050-22

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 14 Dec 2018 to the primary completion date, 30 Nov 2026
  • 4 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior oncological treatment or surgical resection for the present disease

Other illness

  • 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
  • Known hypersensitivity to any contents of the study drugs
  • Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial

Other

  • Neuroendocrine or adenosquamous carcinoma
  • Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
  • Pregnancy (positive pregnancy test) and/or breast feeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oslo University Hospital HF
Coordinator of this site? Confirm its status		OsloNorwayActive, not recruiting
Region Skane Skanes Universitetssjukhus
Coordinator of this site? Confirm its status		LundSwedenActive, not recruiting
Karolinska University Hospital
Coordinator of this site? Confirm its status		SolnaSwedenActive, not recruiting
Region Kronoberg
Coordinator of this site? Confirm its status		VaxjoSwedenActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.