rectal carcinoma MedDRA version: 6.1 Level: PT Classification code 10062099
Conditions
Interventions
Product Name: Panitumumab
Pharmaceutical Form: Solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: ELOXATIN*IV 1FL POLV 50MG
Phar
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically confirmed diagnosis of rectal cancer ? Adenocarcinoma of the middle and /or lower rectum (within 12 cm from the anal verge) ? Karnofski Performance Status: >=70% ? Age > 18 years ? Stage uT3N+M0 and uT4 N-/+ M0 ? Neutrophilis > 1.5 x 109/L and Platelets >100 x 109/L ? Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Prior radiotherapy or chemotherapy for rectal cancer ? Other prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years ? Unstable cardiac pathologies requiring treatment: congestive heart failure, myocardial infarction within 1 year from study entry or unstable angina, uncontrolled high risk hypertension or arrhythmias ? Other serious or unstable metabolic diseases ? Serious uncontrolled active infection ? History of significant neurological or psychiatric disorders, including dementia or seizures ? Patients who are unable or unwilling to take oral medication or have had prior surgical procedures affecting absorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the complete pathological response rate over the treatment period when panitumumab, 5-fluorouracil and oxaliplatin are administered in combination with external beam radiotherapy in Subjects with untreated resectable and locally advanced rectal cancer;Secondary Objective: To assess the pathological downstaging, the RO resection rate, the sphincter-saving surgery, the time of progression free survival and overall survival To assess the safety of the pre-operative treatment with panitumumab, 5-fluorouracil, oxaliplatin in combination with pelvic radiotherapy;Primary end point(s): Pathological complete response rate (pCR) over the entire treatment period: Incidence of pathological complete response (combination, or monotherapy); subjects prematurely discontinuing without a post-baseline tumour response assessment or subjects with an observed complete or partial response that is not confirmed will be considered non-responders. Appendix 3 details the histopathological response criteria, a total regression is considered | — |
Countries
Italy
Outcome results
None listed