Resectabel gastric and gastroesophageal junction adenocarcinoma. MedDRA version: 21.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Irinotekan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Skåne University Hospital, Department of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically verified, resectable gastric or GE junction (Siewert type I-III) adenocarcinoma • 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 o hepatic: bilirubin = 1.5 x ULN, ALAT = 3 x ULN o renal: creatinine = 1.5 x ULN • Fertile men and women must use highly effective means of contraception (failure rate =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of histopathological response according to Becker criteria. ;Secondary Objective: •To determine the rate of R0-resection •To determine treatment completion rate •To determine DFS •To determine OS •To determine treatment related toxicity and complications ;Primary end point(s): Histopathological response rate.;Timepoint(s) of evaluation of this end point: Within 30 Days post surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Microscopically radical resection rate: Within 30 Days post surgery. Treatment completion rate: After completion of neoadjuvant and adjuvant chemotherapy. Disease free survival and overall survival: At follow up 12, 18, 24, 30, 36, 48 and 60 months from registration. Toxicity: Continuous during study treatment and then another 4 weeks. Complications: Within 30 days from surgery.;Secondary end point(s): Microscopically radical resection rate. Treatment completion rate Disease free survival Overall survival Toxicity Complications | — |
Countries
Sweden
Contacts
Public ContactDavid Borg
Skåne University Hospital, Department of Oncology
Outcome results
None listed