Chimiothérapie d’induction suivie d’une radiochimiothérapie préopératoire à base de cisplatine, 5FU et panitumumab dans le traitement des cancers oesogastriques avancés et opérables

• Conditions: locally advanced oeso-gastric adenocarcinomas

• Registration Number: EUCTR2009-015402-19-BE
• Lead Sponsor: B Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-07
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 49

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:
oNeutrophil count =1.5x109/L
oPlatelet count =100x109/L
oLeucocyte count > 3,000/mm
o Hemoglobin > 9 g/dL

•Hepatic Function:
oTotal bilirubin = 1.5 time the upper normal limit (UNL)
oASAT = 2.5xUNL
oALAT = 2.5xUNL
•Renal Function
oCreatinine 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

•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:
oCuratively resected non-melanomatous skin cancer
oCuratively treated cervical carcinoma in situ
oOther 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified