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

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

July 31, 2017

Study Completion Date

March 12, 2018

Conditions
Rectal Cancer
Interventions
DRUG

FOLFOXIRI 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)."

OTHER

Chemoradiotherapy 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)."

Trial Locations (4)

35128

Irccs Istituto Oncologico Veneto, Padua

53100

Dipartimento Oncologico AUSL 7, Siena

56100

Polo Oncologico Area Vasta Nord Ovest, Pisa

ausl5 di Pisa, Pontedera

All Listed Sponsors
lead

Azienda Ospedaliero, Universitaria Pisana

OTHER

NCT03085992 - Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer | Biotech Hunter | Biotech Hunter