Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Colorectal Cancer
Interventions
DRUG

Irinotecan

Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles

DRUG

5-Fluorouracil

5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles

DRUG

Leucovorin

Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles

DRUG

Capecitabine

Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles

DRUG

Bevacizumab

Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles

DRUG

Bevacizumab

Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles

DRUG

Irinotecan

Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles

Trial Locations (8)

Unknown

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli

"IASO General Hospital of Athens, 1st Dep of Medical Oncology", Athens

"Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine", Athens

401 Military Hospital of Athens, Athens

Air Forces Military Hospital of Athens, Athens

State General Hospital of Larissa, Larissa

"Metaxa's Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology", Piraeus

"Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology", Thessaloniki

All Listed Sponsors
collaborator

University Hospital of Crete

OTHER

lead

Hellenic Oncology Research Group

OTHER