FLUOROURACIL for Resectable gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Histologically verified, resectable gastric or GE junction (Siewert type I-III) adenocarcinoma"}
• {"criterion_text":"- The patient must be able to comply with the protocol"}
• {"criterion_text":"- Confirmation of patient operability by surgeon"}
• {"criterion_text":"- TNM (8th edition): cT2-4a or cN+, cM0"}
• {"criterion_text":"- Age: 18 years or older"}
• {"criterion_text":"- WHO performance status ≤ 1"}
• {"criterion_text":"- Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Signed written informed consent"}

Exclusion criteria

• {"criterion_text":"- Neuroendocrine or adenosquamous carcinoma"}
• {"criterion_text":"- Prior oncological treatment or surgical resection for the present disease"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Active inflammatory bowel disease"}
• {"criterion_text":"- Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)"}
• {"criterion_text":"- Known hypersensitivity to any contents of the study drugs"}
• {"criterion_text":"- Pregnancy (positive pregnancy test) and/or breast feeding"}
• {"criterion_text":"- Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial"}

Primary endpoints

• {"endpoint_text":"- Histopathological response rate within 30 days post surgery","definition_or_measurement_approach":"Measured as histopathological response rate within 30 days post surgery according to the Becker criteria (\"To determine the rate of histopathological response according to Becker criteria\")."}

Secondary endpoints

• {"endpoint_text":"- Microscopically radical resection rate: Within 30 Days post surgery","definition_or_measurement_approach":"Microscopically radical (R0) resection rate assessed within 30 days post surgery."}
• {"endpoint_text":"- Treatment completion rate: After completion of neoadjuvant and adjuvant chemotherapy.","definition_or_measurement_approach":"Proportion of patients completing planned neoadjuvant and adjuvant chemotherapy (assessed after completion)."}
• {"endpoint_text":"- Disease free survival and overall survival: At follow up 12, 18, 24, 30, 36, 48 and 60 months from registration.","definition_or_measurement_approach":"DFS and OS measured at scheduled follow-up timepoints (12, 18, 24, 30, 36, 48 and 60 months from registration)."}
• {"endpoint_text":"- Toxicity: Continuous during study treatment and then another 4 weeks","definition_or_measurement_approach":"Adverse events/toxicity monitored continuously during study treatment and for 4 weeks after treatment."}
• {"endpoint_text":"- Complications: Within 30 days from surgery","definition_or_measurement_approach":"Surgical and treatment-related complications recorded within 30 days from surgery."}

Sweden

Earliest CTIS Part Ii Submission Date

22-04-2024

Latest Decision Or Authorization Date

22-05-2024

Processing Time Days

30

Number Of Sites

3

Number Of Participants

44

Norway

Earliest CTIS Part Ii Submission Date

22-04-2024

Latest Decision Or Authorization Date

21-05-2024

Processing Time Days

29

Number Of Sites

1

Number Of Participants

13

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden