locally advanced oeso-gastric adenocarcinomas
Conditions
Interventions
Trade Name: Vectibix 20 mg/ml concentration
solution for infusion
Product Name: panitumumab
Product Code: AMG 954
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITU
Sponsors
ULB Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Locally advanced gastric and EG junction adenocarcinoma with histological proof > T2a-N0 (including T2a-T3-T4 and N0 or N+). • Patient = 18 years of age. • PS 0-1. • Potentially resectable tumor. • Operable patient without major comorbidities (cardiovascular, pulmonary, neurological). • Adequate liver, renal and hematological functions. • Haematology: o Neutrophil count =1.5x109/L o Platelet count =100x109/L o Leucocyte count > 3,000/mm o Hemoglobin > 9 g/dL • Hepatic Function: o Total bilirubin = 1.5 time the upper normal limit (UNL) o ASAT = 2.5xUNL o ALAT = 2.5xUNL • Renal Function o Creatinine clearance =50 mL/min and serum creatinine =1.5xUNL • Metabolic Function o Magnesium = lower limit of normal. o Calcium = lower limit of normal. • Competent to comprehend, sign, and date the IEC/IRB approved written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Evidence of distant metastases including distant lymph nodes (including supraclavicular, hepatoduodenal, retropancreatic, mesenteric and paraaortic). • Patients with non operable tumor. • Prior therapy for upper GI cancer. • Other histological types than adenocarcinoma. • History of other primary cancer, unless: o Curatively resected non-melanomatous skin cancer o Curatively treated cervical carcinoma in situ o Other primary solid tumor curatively treated with no known active disease present and no treatment administered for = 5 years before enrollment • Presence of peripheral neuropathy > grade 1 according to CTCAE. • Presence of uncontrolled comorbidities. • Presence of organ allografts requiring immunosuppression. • Administration of any investigational drug or procedure in the setting of another trial. • Major surgery within 30 days before inclusion. • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ? 1 year before enrollment/randomization • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. • Known allergy or hypersensitivity to any component of panitumumab and/or chemotherapy used • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection • Subject unwilling or unable to comply with study requirements • Previously enrolled into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and tolerance of incorporating an anti EGF-R therapy in a multimodality combination based on platinum-5FU and radiotherapy in the preoperative setting of locally advanced resectable EJ junction and gastric adenocarcinoma. ;Secondary Objective: Secondary endpoints: Pathologic complete response (ypT0N0) rate R0 resection rate Metabolic response after chemotherapy as a predictor of histopathologic response 30 day postop complications rate DFS OS General safety profile Predictive biomarkers of histopathologic response (TR part) ;Primary end point(s): •Treatment feasibility will be assessed using two co-primary endpoints: treatment completion and excessive toxicity. Treatment will be considered as complete if chemotherapy, chemoradiation (both including panitumumab treatment) and surgery have been administered. The relative dose intensity of the CT and CT/RT needs also to be >= 80%. The relative dose intensity will be calculated for each drug and for radiotherapy (ratio of delivered dose intensity to the planned dose intensity) and averaged over all drugs and RT. The mean has to be >=80% to consider that treatment has been completed. The trial makes use of a Bryant and Day design and maybe stopped early in case of excessive toxicity or in case of too low completion rate (see statistical considerations). Excessive toxicity is defined as the occurrence of grade 4 toxicity plus hospitalization or the occurrence of toxic death (grade 5). | — |
Countries
Belgium
Outcome results
None listed