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NCT Number: NCT03773367

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Resectable Gastric and Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oslo University Hospital, Ullevål Hospital, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil

Drug

Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.

Oxaliplatin

Drug

Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.

Irinotecan

Drug

Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.

Primary outcomes

  1. To determine the rate of histopathological response according to Becker criteria.

    Time frame: After surgery.

    Assessment of histopathological response, ypTNM, resection margin and residual tumor status. If Laurén classification and mismatch repair (MMR) or microsatelite instability status (MSI) could not be assessed on pretreatment biopsies it should be assessed on the resected specimen. Results do not have to be awaited before start of chemotherapy.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Acronym: INTENSE

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2018
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.