Clinical trial NCT03773367: Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Official title: Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To determine the rate of histopathological response according to Becker criteria.
timeFrame: After surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Växjö
country: Sweden
facility: Centrallasarettet i Växjö
Study officials:
References: