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

NCT03773367 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SEGCG18-01
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Resectable Gastric and Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric adenocarcinoma; Gastroesophageal junction adenocarcinoma; Chemotherapy; Fluorouracil; Oxaliplatin; Irinotecan; Preoperative chemotherapy; Postoperative chemotherapy; Histopathological response; Rate of R0-resection

Outcome Measures

Primary Outcomes (1)

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

  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.

  After surgery.

Study Arms (1)

Treatment with chemotherapy pre- and postoperative.

EXPERIMENTAL

Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Irinotecan

Interventions

Fluorouracil DRUG

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

Treatment with chemotherapy pre- and postoperative.

Oxaliplatin DRUG

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

Treatment with chemotherapy pre- and postoperative.

Irinotecan DRUG

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

Treatment with chemotherapy pre- and postoperative.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (4)

Oslo University Hospital, Ullevål Hospital

Oslo, 0450, Norway

Location

Lund University Hospital

Lund, 221 85, Sweden

Location

Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Centrallasarettet i Växjö

Vaxjo, 352 34, Sweden

Location

MeSH Terms

Interventions

Fluorouracil; Oxaliplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: December 14, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); SE (3)