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POST-SURGICAL LIQUID BIOPSY - GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS - THE PEGASUS TRIAL

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517704-10-00
Enrollment
156
Registered
2024-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Brief summary

Number of post-surgery false negative cases after a double ctDNA-negative detection, defined as cases that become positive at subsequent interventional LB and/or that experience radiological relapse within 2 years.

Detailed description

Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5- years., Safety and tolerability according to CTCAE version 5.0., Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any chemotherapy regimen remaining disease free at 2 and 3 years., Assessment of QLQ-C30 and CR-29 EORTC questionnaires.

Interventions

DRUGCAPECITABINE
DRUGOXALIPLATIN
DRUGFLUOROURACIL
DRUGIRINOTECAN

Sponsors

IFOM Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of post-surgery false negative cases after a double ctDNA-negative detection, defined as cases that become positive at subsequent interventional LB and/or that experience radiological relapse within 2 years.

Secondary

MeasureTime frame
Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5- years., Safety and tolerability according to CTCAE version 5.0., Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any chemotherapy regimen remaining disease free at 2 and 3 years., Assessment of QLQ-C30 and CR-29 EORTC questionnaires.

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026