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INDUCTION TREATMENT WITH FOLFOXIRI PLUS BEVACIZUMAB FOLLOWED BY PREOPERATIVE CHEMORADIOTHERAPY PLUS BEVACIZUMAB

* BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
* IRINOTECAN 165 mg/sqm IV over 1-h, day 1
* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
* L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
* 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1 administered every two weeks for 6 cycles (3 months).

FOLFOXIRI plus Bevacizumab

* FLUOROURACIL 225 mg/sqm/day by protracted IV continuous infusion or -CAPECITABINE 825 mg/sqm/bid p.o. continuously without interruption for all the duration of radiation treatment;
* EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 daily fractions over 5.5 weeks;
* BEVACIZUMAB 5 mg/kg over 30 minutes, starting on day 1 of radiation treatment day 1 and then every two weeks (for 3 cycles).

Chemoradiotherapy plus Bevacizumab

Alfredo Falcone, MD

This study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free survival at two years. Translational analyses will be performed to show the presence of VEGF polymorphism, CD133 surface markers on colorectal CSCs.

Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer

Open-label Phase II Study of Induction Treatment With Folfoxiri Plus Bevacizumab Followed by Preoperative Chemoradiotherapy Plus Bevacizumab in Patients With Locally Advanced, Resectable Rectal Cancer.

Disease-free survival is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment.

Response rate is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria vers. 1.1.

Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing treatment-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria (version 3.0), during induction and concomitant chemoradiotherapy

Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.

Pathological complete response rate is defined as the fraction of treated patients who achieve pathological response after treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer	NCT03085992	Rectal Cancer	FOLFOXIRI plus ... Chemoradiothera...	18 Years - 75 Years	Azienda Ospedaliero, Universitaria Pisana
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer	NCT03085992	Rectal Cancer	FOLFOXIRI plus ... Chemoradiothera...	18 Years - 75 Years	Azienda Ospedaliero, Universitaria Pisana

Spots Global Cancer Trial Database for chemoradiotherapy plus bevacizumab