Xeloda and Bevacizumab to Treat Rectal Cancer (NCT00847119) | Clinical Trial Compass
CompletedPhase 2
Xeloda and Bevacizumab to Treat Rectal Cancer
Spain43 participantsStarted 2007-09
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patient has given written informed consent prior to any study related procedure
✓. Male and female aged 18 to 75 years
✓. ECOG performance status 0 or 1
✓. Histologically confirmed diagnostic of adenocarcinoma of the rectum \< 15 cm from anal verge
✓. Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
✓. Disease evaluable by imaging techniques
✓. No tumour haemorrhage in the week prior to start of study treatment
✓. External derivation in symptomatic occlusive tumours
Exclusion criteria
✕. Rectal cancer no amenable to resection
✕. Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
✕. Pregnant or breast-feeding women
✕. Women oh childbearing potential unless effective methods of contraception are used
✕. No prior or concurrent significant medical conditions, including any of the following:
What they're measuring
1
Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)