POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF COLON CANCER PATIENTS

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 140

Inclusion Criteria

1. Pegasus trial written informed consent.
2. Age = 18 years.
3. Histologically confirmed diagnosis of operable stage III or T4N0 stage II colon
cancer located 12 cm from the anal verge by endoscopy and above the peritoneal
reflection at surgery.
4. Availability of plasma collected prior to surgery.
5. Availability of the original FFPE tumor tissue.
6. Acceptance to undergo at least all the interventional liquid biopsies.
7. ECOG performance status 0-1.
8. Normal organ functions. (as defined in section 9.3)
9. Women with childbearing potential should complete a pregnancy test and be willing to
use highly effective contraceptive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Patients having a MSI-H/MMRd tumor are excluded from the study (done according to
standard clinical practice).
2. History of another neoplastic disease, unless in remission for = 5 years.
Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin,
or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have
undergone potentially curative therapy are not excluded.
3. Had an incomplete diagnostic colonoscopy and/or polyps removal.
4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients
should never have had any evidence of metastatic disease (including presence of tumor
cells in the peritoneal lavage).
5. Current or recent treatment with another investigational drug or participation in
another investigational study
6. Patient unable to comply with the study protocol owing to psychological, social or
geographical reasons.
7. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study.
8. Inadequate contraception (male or female patients) if of childbearing or
procreational potential.
9. Clinically relevant cardiovascular disease.
10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of
the components of the treatment.
12. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
13. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is
required.
15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive)or known active Hepatitis C virus infection. Note: no testing for Hepatitis B
and Hepatitis C isrequired unless mandated by local health authority.
16. Has a known history of active TB (Bacillus