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

Resectable Gastric and Gastroesophageal Junction Adenocarcinoma Clinical Trial

— INTENSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03773367
• Other study ID #: SEGCG18-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 14, 2018
• Est. completion date: May 31, 2026

Study information

• Verified date: January 2024
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Resectable Gastric and Gastroesophageal Junction Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevål Hospital	Oslo
Sweden	Lund University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm
Sweden	Centrallasarettet i Växjö	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.