The Sagittarius Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

October 22, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

September 1, 2028

Conditions
Colon Cancer Stage IIColon Cancer Stage III
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (26)

10060

RECRUITING

Istituto di Candiolo, Candiolo

10117

RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

13875

RECRUITING

Azienda Sanitaria Locale di Biella, Biella

14004

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

15706

RECRUITING

Hospital Clínico Universitario de Santiago, Santiago de Compostela

16132

RECRUITING

Azienda Ospedaliera Universitaria San Martino, Genova

20089

RECRUITING

Istituto Clinico Humanitas, Rozzano

20141

RECRUITING

Istituto Europeo di Oncologia, Milan

20162

RECRUITING

Ospedale Niguarda, Milan

25124

RECRUITING

Fondazione Poliambulanza, Brescia

28040

RECRUITING

Hospital Clinico Universitario San Carlos, Madrid

28100

RECRUITING

Ospedale Maggiore di Novara, Novara

31008

RECRUITING

Complejo Hospitalario de Navarra, Pamplona

39008

RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

43126

RECRUITING

Azienda Ospedaliera Universitaria di Parma, Parma

46010

RECRUITING

INCLIVA Instituto de Investigación Sanitaria, Valencia

46014

RECRUITING

Hospital General Universitario de Valencia, Valencia

48121

RECRUITING

Azienda Unità Sanitaria Locale della Romagna, Ravenna

50009

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

06129

RECRUITING

Ospedale Santa Maria della Misericordia, Perugia

00168

RECRUITING

Policlinico Universitario Gemelli, Roma

08003

RECRUITING

Hospital del Mar, Barcelona

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08041

RECRUITING

Hospital Sant Pau Barcelona, Barcelona

08208

RECRUITING

Consorci Corporació Sanitària Parc Taulí, Barcelona

08908

RECRUITING

Instituto Catalán de Oncologia, Barcelona

All Listed Sponsors
lead

IFOM ETS - The AIRC Institute of Molecular Oncology

OTHER