The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
Institut Català d'Oncologia-L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona, Spain
Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)
Time frame: Surgery date
Overall clinical response
Time frame: Surgery date
To determine the downstaging caused by treatment
Time frame: Surgery date
relapse free survival
Time frame: Time of radiological evidence of relapse.
Quantify the local control grade: R0 resections in surgery
Time frame: Surgery date
Local relapse and distant relapse rates
Time frame: Relapse date
To determine the security profile of this neoadjuvant treatment (radio- chemotherapy)
Time frame: From date of register to surgery date
Surgery complication rate
Time frame: During surgery admission.
To determine the angiogenic profile changes in tumour.
Time frame: 15 days, 6 weeks and 4 months
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