Advanced Rectal Carcinoma MedDRA version: 14.1 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: AVASTIN*INFUS 1FL 100MG 4ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: NA
Other descriptive n
Sponsors
ARCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven diagnosis of rectal adenocarcinoma. Diagnosis obtained by a biopsy technique which leaves the major portion of the tumor intact. - Locally advanced, resectable disease defined by the presence of at least one of the following features: tumour extending to within 1 mm of or beyond the mesorectal fascia (ie, circumferential radial margin threatened or involved); lower third (= 6 cm from the anal verge) cT3 tumours; tumour extending 5 mm or more into perirectal fat; T4 tumour (ie, invading surrounding structures or peritoneum); clinical stage III disease (T1-4, N1-2), with the definition of a clinically positive lymph node being any node = 1.0 cm; - Distal border of the tumor must be located ULN, serologic testing for Hepatitis B and C must be negative]. - Renal: creatinine clearance > 50 mL/min; no renal disease that would preclude study treatment or follow-up. -Written informed consent to experimental treatment and pharmacogenomic analyses. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Previous treatment with oxaliplatin, irinotecan or bevacizumab. Previous 5-fluorouracil or capecitabine treatment is allowed. - Previous pelvic radiation therapy. - Hepatic disease that would preclude study treatment or follow-up; uncontrolled coagulopathy; history of viral hepatitis or other chronic liver disease. - Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia; uncontrolled hypertension. - Lack of upper gastrointestinal tract integrity or malabsorption syndrome; active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic). - Pregnant or lactating women. Fertile patients must use effective contraception. - Patients with prior malignancies (with the exception of rectal cancer), including invasive colon cancer, are eligible provided they have been disease-free for = 5 years and are deemed by their physician to be at low risk for recurrence. - Other malignancy within the past 5 years with the exception of effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum. - Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan or to Chinese hamster ovary cell proteins. - Clinically significant peripheral neuropathy (i.e., neurosensory or neuromotor toxicity = grade 2). - Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the disease-free survival rate (comprising local relapse, distant relapse, second primary tumors or death) at 2 years in patients with locally advanced resectable rectal cancer treated with 3 months of induction treatment with the FOLFOXIRI regimen plus bevacizumab followed by chemoradiotherapy comprising radiation therapy and a fluoropyrimidine plus bevacizumab;Secondary Objective: • Evaluate the rate of clinical objective responses in treated patients. • Evaluate the rate of pathologic complete responses in treated patients. • Determine the feasibility and safety of the tested strategy. • Evaluate the overall survival of treated patients. • Correlate the radiographic and radionuclide responses to preoperative treatment with pathologic response and outcome. • Correlate genetic patterns and the presence or absence of specific tissue and blood biomarkers with response and prognosis in treated patients;Primary end point(s): disease-free survival rate;Timepoint(s) of evaluation of this end point: disease-free survival rate (comprising local relapse, distant relapse, second primary tumors or death) at 2 years in patients with locally advanced resectable rectal cance | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluate the rate of clinical objective responses in treated patients. • Evaluate the rate of pathologic complete responses in treated patients. • Determine the feasibility and safety of the tested strategy. • Evaluate the overall survival of treated patients. • Correlate the radiographic and radionuclide responses to preoperative treatment with pathologic response and outcome. • Correlate genetic patterns and the presence or absence of specific tissue and blood biomarkers with response and prognosis in treated patients.;Timepoint(s) of evaluation of this end point: 42 months / end of the study | — |
Countries
Italy
Contacts
Public ContactUfficio Sperimentazioni
U.O. Oncologia Medica - Az Ospedaliero-Universitaria Pisana
Outcome results
None listed