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Irinotecan-based triplet (FOLFOXIRI) as perioperative treatment in resectable gastric and gastroesophageal junction adenocarcinoma - a phase II, single-arm, multicenter, clinical trial within the Scandinavian Esophageal and Gastric Cancer Group (SEGCG)
EU CTIS ID: 2023-509044-96-00
What this study is testing
To determine the rate of histopathological response according to Becker criteria
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically verified, resectable gastric or GE junction (Siewert type I-III) adenocarcinoma
- The patient must be able to comply with the protocol
- Confirmation of patient operability by surgeon
- TNM (8th edition): cT2-4a or cN+, cM0
- Age: 18 years or older
- WHO performance status ≤ 1
You likely can't join 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)
See the full eligibility criteria
- Histologically verified, resectable gastric or GE junction (Siewert type I-III) adenocarcinoma
- The patient must be able to comply with the protocol
- Confirmation of patient operability by surgeon
- TNM (8th edition): cT2-4a or cN+, cM0
- Age: 18 years or older
- WHO performance status ≤ 1
- Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
- Adequate laboratory findings: o 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 ULN, ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN
- For fertile women and for men in sexual relationship with fertile women it is mandatory, during the study treatment period and for 6 months further, to use highly effective means of contraception (failure rate < 1%) such as:o combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration) o progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration) o intrauterine device o intrauterine hormone-releasing system o bilateral tubal occlusion o vasectomised partner o sexual abstinence (defined as refraining from heterosexual intercourse) given that it is the ususal and preferred lifestyle of the patient
- Signed written informed consent
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.