Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer
- Written informed consent
- Age ≥18 years
- ECOG ≤ 1
- Histologically confirmed carcinoma of the rectum
- Localized and resectable rectal cancer
- No metastatic disease
- Measurable disease
- Life expectancy more than 4 months
- Non prior treatment for rectal cancer
- Adequate haematological function: leu ≥ 4x 109 /l, Hb ≥10 gr/dl, neutropils≥ 1,5 x
109 /l and platelets ≥100 x 109 /l
- Adequate renal function: creatinine ≤ 106 umol/l or calculated creatinine clearance >
- Adequate liver function: AST, ALT and alkaline phosphatase ≤2.5 x UL, bilirubin ≤1.5
- Adequate nutritional weight loss <10% of regular weight and albumin ≥ 35 g/l
- Unresectable rectal cancer
- Past or current history (within the last 5 years prior to treatment start) of other
- Patients of childbearing potential not willing to use effective means of
- Clinically significant cardiovascular disease
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome or inability to take oral medication.
- Patients subjected to organ allografts who require immunosuppressive treatment.
- Severe, non-cicatrized osseous fractures, wounds or ulcers.
- Indications of hemorrhagic diathesis or coagulopathy.
- Severe, uncontrolled intercurrent infections or other severe, uncontrolled
- History of unexpected severe reactions to treatment with fluoropyrimidines or known
deficiency dihydropyrimidine dehydrogenase deficiency (DPD).
- Patients subjected to a major surgical procedure, open biopsy or who have had
significant traumatic lesions within the 28 days prior to beginning the treatment of
the study or in whom it is foreseen that a major surgical procedure will be necessary
during the course of the study; fine-needle aspiration within the 7 days prior to
beginning the treatment of the study.
- Current or recent use (within the 10 days prior to beginning the treatment of the
study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents.
The use of low doses of warfarin is allowed, with an International Normalized Ratio
[INR] of < 1.5.
- Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid
anti-inflammatory medications (which inhibit the platelet function at doses used for
treating chronic inflammatory diseases).
- Patients who have received any drug or agent/procedure under research, i.e., who have
participated in another clinical trial during the 4 weeks prior to beginning the
treatment with the medications of the study
- Any psychological, familiar conditions suggesting that the patient will not be able
to complete the study