Operable locally advanced rectal cancer MedDRA version: 14.1 Level: LLT Classification code 10038019 Term: Rectal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VECTIBIX*INFUS 1FL 20ML 20MG/M
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
FONDAZIONE DELL'ISTITUTO TOSCANO TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge); KRAS wild type; age =18 years; Karnofsky performance status of =70 at study entry; clinical stage T3 N- M0 or cT2-T3 N+ M0 - CRM; hemoglobin = 9 g/dl; neutrophils = 1.5 x 10^9/L; platelets = 100 x 10^9/L; bilirubin level =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: Prior radiotherapy or chemotherapy for rectal cancer; concurrent chronic systemic immune therapy; any investigational agent(s); previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy; clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months; known grade 3 or 4 allergic reaction to any of the components of the treatment; known drug abuse/ alcohol abuse; legal incapacity or limited legal capacity; medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed; women who are pregnant or breastfeeding consent; acute or subacute gastro-intestinal occlusion; any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the complete pathological response rate after the pre-operative treatment with panitumumab in combination with external pelvic radiotherapy;Secondary Objective: To assess safety, pathological downstaging, R0 (surgical margin >1 mm/CRM-) resection rate, sphincter-saving surgery, time of disease free survival and overall survival, correlation between bio-markers and pathological responses;Primary end point(s): Pathological Complete Response Rate (pCR);Timepoint(s) of evaluation of this end point: According to the therapeutic protocol timing, the surgery would be completed within 14 weeks from the patient's registration. Assuming that pathological results will be available 15 days later, the primary endpoint will me measured 16 weeks after the enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pathological downstaging rate, sphincter saving surgery rate, disease-free survival, R0 resection rate, time to relapse following surgery, overall survival time, incidence and severity of adverse events, significant laboratory changes, changes in vital signs, incidence of concomitant medications, changes from baseline over time in Karnofski performance status.;Timepoint(s) of evaluation of this end point: The evaluation of secondary endpoints will be completed within 60 months from the enrollment | — |
Countries
Italy
Contacts
Public ContactCentro Coord.Sperim.Cliniche
AOU CAREGGI
Outcome results
None listed