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

NCT ID: NCT03773367

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with chemotherapy pre- and postoperative.

Group Type: EXPERIMENTAL

Fluorouracil

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Irinotecan

Intervention Type: DRUG

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

Interventions

Fluorouracil

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Irinotecan

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oslo University Hospital, Ullevål Hospital

Oslo, , Norway

Lund University Hospital

Lund, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Centrallasarettet i Växjö

Vaxjo, , Sweden

Countries

Norway; Sweden

Other Identifiers

SEGCG18-01

Identifier Type: -

Identifier Source: org_study_id