Status:
ACTIVE_NOT_RECRUITING
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Lead Sponsor:
Lund University Hospital
Conditions:
Resectable Gastric and Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fluorourac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03773367
Start Date
December 14 2018
End Date
November 30 2026
Last Update
September 10 2025
Active Locations (4)
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1
Oslo University Hospital, Ullevål Hospital
Oslo, Norway, 0450
2
Lund University Hospital
Lund, Sweden, 221 85
3
Karolinska University Hospital
Stockholm, Sweden, 141 86
4
Centrallasarettet i Växjö
Vaxjo, Sweden, 352 34