Post-surgical Liquid Biopsy-guided Treatment of Stage III and High-risk Stage II Colon Cancer Patients: the PEGASUS Trial

PHASE2UnknownINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 16, 2020

Primary Completion Date

July 15, 2024

Study Completion Date

October 15, 2024

Conditions
Colon Cancer
Interventions
DRUG

CAPOX

"DAY 1~* OXA 130 mg/m2 administered as intravenous infusion over 2 hours in 250 mL dextrose 5%~* CAPE 1000 mg/m2 administrated per os twice daily~DAY 2-14~• CAPE 1000 mg/m2 os twice daily~Cycle length is 3 weeks comprising 2 hours of oxaliplatin infusion every 21 days, 14 days of oral capecitabine and 7 days of resting."

DRUG

Capecitabine

"DAY 1-14~• CAPE 1250 mg/m2 os twice daily~Cycle length is 3 weeks comprising 14 days of oral capecitabine and 7 days of resting."

DRUG

FOLFIRI

"Day 1:~* IRI, 180 mg/m2 administered as iv infusion over 30-90 minutes in 250 mL dextrose 5%, concurrently (via a Y-connector) with~* LV, 400 mg/m2 administered as an iv infusion over 2 hours, in 250 mL dextrose 5%, followed by~* 5-FU, 400 mg/m2 administered as a bolus injection (iv push administered by hand) and then at 2400 mg/m2 administered as a iv infusion over 46 hours.~Cycle length is 2 weeks comprising approximately 48 hours of infusion and 12 days of rest."

Trial Locations (11)

48121

AULS della Romagna, Ravenna

Unknown

Ospedale Policlinico San Martino IRCCS, Genova

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

Istituto Europeo di Oncologia IRCCS, Milan

Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan

Istituto Oncologico Veneto IRCCS, Padua

University Hospital del Mar, Barcelona

Vall d'Hebron Institute of Oncology, Barcelona

INCLIVA Biomedical Research Institute, Valencia

06132

Ospedale Santa Maria della Misericordia, Perugia

08970

Hospital Moises Broggi, Sant Joan Despí

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Guardant Health, Inc.

INDUSTRY

lead

IFOM ETS - The AIRC Institute of Molecular Oncology

OTHER