Gastric cancer MedDRA version: 12.1 Level: LLT Classification code 10017764 Term: Gastric cancer stage II MedDRA version: 12.1 Level: LLT Classification code 10017765 Term: Gastric cancer stage III MedDRA version: 12.1 Level: LLT Classification code 10017768 Term: Gastric cancer stage IV without metastases
Conditions
Interventions
Trade Name: Vectibix 20 mg/ ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Panitumumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
AGMT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Signed informed consent •untreated, histologically confirmed, non-metastasizing, resectable gastric or esophageal adenocarcinoma •KRAS wild type tumor •T2-4 NX M0 disease – see appendix 5 •ECOG performance status 0 or 1 •Patiente 18 to 65 years old •Ability to understand and comply with requirements of study protocol and trial partici-pation •Patients of either sex are eligible for study entry. Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception (e.g. intrauterine device (IUD), birth control pills, or barrier device) during treatment and for 6 months following the last dose of Pmab. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Pregnant or breast feeding women. •Women of child-bearing potential and men not willing to use effective contraception during treatment and for 6 months after the end of treatment with Pmab •Previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix. •Active bacterial, viral or fungal infection (including acute or chronic-active infection with HBV or HCV). •Arterial or venous thromboembolism within 6 months before enrollment •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess activity of concurrent EOC and Pmab in study patients, measured by proportion of patients with stage T0 and T1 after neoadjuvant study treatment, according to oesophago-gastroscopic endosonography. To assess the tolerability / feasibility of concurrent EOC and Pmab in study patients, measured by proportion of patients with grade 4 diarrhea.;Secondary Objective: To assess: •activity of study treatment, measured by proportion of patients with com-plete (R0) tumour resection and patients with downstaging of their disease during study treatment, according to oesophago-gastroscopic endosonography •the rate of pathologic complete responses in referred to surgery after completion of study treatment •progression-free survival and overall survival 12 months after surgery / end of study treatment •the rate of both treatment-related and –unrelated (severe) adverse events in study patients, measured by CTCAE grades •the tolerability / feasibility of concurrent EOC and Pmab in study patients, measured by proportion of patients completing 3 cycles of concurrent EOC and Pmab;Primary end point(s): To assess activity of concurrent EOC and Pmab in study patients, measured by proportion of patients with stage T0 and T1 after neoadjuvant study treatment, according to oesophago-gastroscopic endosonography. To assess the tolerability / feasibility of concurrent EOC and Pmab in study patients, meas-ured by proportion of patients with grade 4 diarrhea. | — |
Countries
Austria
Outcome results
None listed