700
Participants
Start Date
October 22, 2024
Primary Completion Date
March 1, 2026
Study Completion Date
September 1, 2028
Oxaliplatin
"Oxaliplatin is used as part of the chemotherapy regimens for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways:~CAPOX Regimen: Oxaliplatin 130 mg/m² is given intravenously on day 1, in combination with capecitabine 1000 mg/m² taken orally twice daily on days 1-14 of each 21-day cycle.~FOLFOX Regimen: Oxaliplatin 85 mg/m² is administered intravenously on day 1, alongside folinic acid 400 mg/m² and fluorouracil 400 mg/m² IV bolus, followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle.~Dosages are standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months."
Capecitabine
"Capecitabine is used as part of the chemotherapy regimens for patients with ctDNA+ and ctDNA- results in the SAGITTARIUS trial. It is administered in the following ways:~CAPOX Regimen: Capecitabine 1000 mg/m² is taken orally twice daily on days 1-14 of each 21-day cycle, in combination with oxaliplatin 130 mg/m² given intravenously on day 1.~Capecitabine Monotherapy for High-Risk ctDNA- Patients: Capecitabine 1250 mg/m² is taken orally twice daily on days 1-14 of each 21-day cycle for patients identified as high-risk but with negative ctDNA results.~The dosage of capecitabine is standardized, while the duration of treatment varies based on patient response and monitoring results, typically up to 6 months."
Folinic acid
"Folinic acid is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way:~FOLFOX Regimen: Folinic acid (leucovorin) 400 mg/m² is given intravenously on day 1, in combination with oxaliplatin 85 mg/m² IV on day 1 and fluorouracil 400 mg/m² IV bolus followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle.~The dosage of folinic acid is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months."
Fluorouracil
"Fluorouracil is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way:~FOLFOX Regimen: Fluorouracil 400 mg/m² is given as an intravenous (IV) bolus on day 1, followed by 2400 mg/m² as a continuous IV infusion over 46 hours, in combination with folinic acid (leucovorin) 400 mg/m² IV on day 1 and oxaliplatin 85 mg/m² IV on day 1. This regimen is repeated every 14 days.~The dosage of fluorouracil is standardized, while the duration of treatment is typically up to 6 months, adjusted based on patient response and liquid biopsy results."
Temozolomide
"Temozolomide is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial, specifically for those with MGMT-negative tumors. It is administered in the following way:~TEMIRI Regimen: Temozolomide 150-200 mg/m² is taken orally once daily on days 1-5 of each 28-day cycle, in combination with irinotecan 250 mg/m² administered intravenously on day 1 of each cycle.~The dosage of temozolomide is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
Irinotecan
"Irinotecan is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways:~TEMIRI Regimen: Irinotecan 250 mg/m² is administered intravenously on day 1 of each 28-day cycle, in combination with temozolomide 150-200 mg/m² taken orally once daily on days 1-5.~FOLFIRI Regimen: Irinotecan 180 mg/m² is given intravenously on day 1, in combination with folinic acid (leucovorin) 400 mg/m² IV, fluorouracil 400 mg/m² IV bolus, followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle.~The dosage of irinotecan is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
Nivolumab
"Nivolumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H/MMRd tumors in the SAGITTARIUS trial. It is administered in the following way:~Nivolumab: 3 mg/kg is given intravenously every 2 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
Ipilimumab
"Ipilimumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H/MMRd tumors in the SAGITTARIUS trial. It is administered in the following way:~Ipilimumab: 1 mg/kg is given intravenously every 6 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
Trastuzumab
"Trastuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way:~Trastuzumab: 8 mg/kg as an initial intravenous (IV) loading dose, followed by 6 mg/kg IV every 3 weeks.~The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
Pertuzumab
"Pertuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way:~Pertuzumab: 840 mg as an initial intravenous (IV) loading dose, followed by 420 mg IV every 3 weeks.~The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
Panitumumab
"Panitumumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with multiple wild-type tumors (MSS/MMRp extended RAS/RAF wild-type) in the SAGITTARIUS trial. It is administered in the following way:~Panitumumab: 6 mg/kg is given intravenously every 2 weeks. The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results."
RECRUITING
Istituto di Candiolo, Candiolo
RECRUITING
Charité - Universitätsmedizin Berlin, Berlin
RECRUITING
Azienda Sanitaria Locale di Biella, Biella
RECRUITING
Hospital Universitario Reina Sofia, Córdoba
RECRUITING
Hospital Clínico Universitario de Santiago, Santiago de Compostela
RECRUITING
Azienda Ospedaliera Universitaria San Martino, Genova
RECRUITING
Istituto Clinico Humanitas, Rozzano
RECRUITING
Istituto Europeo di Oncologia, Milan
RECRUITING
Ospedale Niguarda, Milan
RECRUITING
Fondazione Poliambulanza, Brescia
RECRUITING
Hospital Clinico Universitario San Carlos, Madrid
RECRUITING
Ospedale Maggiore di Novara, Novara
RECRUITING
Complejo Hospitalario de Navarra, Pamplona
RECRUITING
Hospital Universitario Marqués de Valdecilla, Santander
RECRUITING
Azienda Ospedaliera Universitaria di Parma, Parma
RECRUITING
INCLIVA Instituto de Investigación Sanitaria, Valencia
RECRUITING
Hospital General Universitario de Valencia, Valencia
RECRUITING
Azienda Unità Sanitaria Locale della Romagna, Ravenna
RECRUITING
Hospital Universitario Miguel Servet, Zaragoza
RECRUITING
Ospedale Santa Maria della Misericordia, Perugia
RECRUITING
Policlinico Universitario Gemelli, Roma
RECRUITING
Hospital del Mar, Barcelona
RECRUITING
Hospital Universitari Vall d'Hebron, Barcelona
RECRUITING
Hospital Sant Pau Barcelona, Barcelona
RECRUITING
Consorci Corporació Sanitària Parc Taulí, Barcelona
RECRUITING
Instituto Catalán de Oncologia, Barcelona
IFOM ETS - The AIRC Institute of Molecular Oncology
OTHER