Locally advanced rectal cancer
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Product Code: RO4876646
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Concentration unit
Sponsors
Onkološki inštitut Ljubljana
Eligibility
Inclusion criteria
Inclusion criteria: •Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum), T3/4 or any node positive disease (clinical stage according the TNM classification system) •No evidence of metastatic disease. •The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation. •Age 18 - 80 years •WHO Performance Status 0-2 •No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer •Adequate hematological, hepatic and renal function as following: - ANC =1.5 x 109/L and Platelets =100 x 109/L - Total bilirubin =1.5 x the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and /or ALAT (SGPT) =2.5 x UNL, alkaline phosphatase =2.5 x UNL - Serum creatinine =1.5 x UNL - Urine dipstick of proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Malignancy of the rectum other than adenocarcinoma •Any unrested synchronous colon cancer • Other co-existing malignancy or malignancy within the last 5 years prior to treatment start, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin •Clinically significant cardiovascular disease, for example CVA, myocardial infarction (within 12 months before treatment start), unstable angina, New York Heart Association (NYHA) > Class II congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension •Any arterial thromboembolic event within 6 months before start of study •Any serious venous thromboembolic event within 3 months before study start •Evidence of active peptic ulcer or upper GI bleeding •Evidence of bleeding diathesis or coagulopathy •Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (> 325 mg/day) or clopidrogel (> 75 mg/day) •Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes •History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures •Serious, non-healing wound, ulcer or bone fracture • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or lack of complete recovery •Acute intra abdominal inflammatory process •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of nvestigational drug or puts the patient at high risk for treatment-related complications •Patients receiving a concomitant treatment with drugs interacting with capecitabin such as flucitosine, phenytoin, or warfarin •Known dihydropyrimidine dehydrogenase (DPD) deficiency •Known hypersensitivity to study drug •Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study •Life expectancy less than 3 months •Pregnant or lactating patient •Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years, hysterectomy or oophorectomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to investigate whether the addition of bevacizumab to preoperative fluoropyrimidine-based chemoradiation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. ;Secondary Objective: • Pathological response rate (plus tumor regression grade according to Dworak scale) • Rate of sphincter sparing surgical procedure • Histopathological R0 resection rate • Acute and late toxicity • Loco-regional failure rate • Disease-free survival • Overall survival • Quality of life ;Primary end point(s): The primary endpoint of the study is pathological complete remission rate. We aim to evaluate whether a 23% pCR rate could be achieved by adding bevacizumab to standard preoperative treatment. | — |
Countries
Slovenia
Outcome results
None listed