Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.
XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)
IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)
IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, Spain
Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria
Time frame: Until the end of study
Study treatment,which selectively omits neoadjuvant irradiation,can achieve a R0= 90%
Time frame: At least 3 years for local recurrence and systemic recurrence
Rate of local and systemic recurrence
Time frame: At least 3 years for local recurrence and systemic recurrence
Toxicity of treatment
Time frame: At least 3 years for local recurrence and systemic recurrence
Rate of surgical complications during postoperative
Time frame: At least 3 years for local recurrence and systemic recurrence
Profile of gene expression before neoadjuvant treatment
Time frame: At least 3 years for local recurrence and systemic recurrence
Complete Phatologic Response (pCR)
Complete pathologic response (pCR)estimated according to the number of subjects that showed yPT0N0 divided by the total number of subjects.
Time frame: 2012
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Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).
825 mg/m2 bid
4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Complejo Sanitario Parc Taulí
Sabadell, Barcelona, Spain
Hospital Arnau de Vilanova
Lleida, Lérida, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital de Navarra
Pamplona, Pamplona, Spain
Hospital La Fe
Valencia, Valencia, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Valencia, Spain
...and 2 more locations