BridgeMD
POST-SURGICAL LIQUID BIOPSY - GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS - THE PEGASUS STUDY
EU CTIS ID: 2024-517704-10-00
What this study is testing
The primary objective is to study the feasibility of using liquid biopsy to guide the post-surgical clinical management of stage III and high-risk stage II (T4N0) MSS colon cancer patients. Feasibility is defined as the ability of at least two subsequent post-surgical negative ctDNA determination to identify patients that will be NED (without radiologic evidence of metastasis) 2 years after surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pegasus trial written informed consent.
- Age ≥ 18 years.
- 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.
- Availability of the original FFPE tumor tissue.
- Availability of plasma collected prior to surgery.
- Acceptance to undergo at least all the interventional liquid biopsies.
You likely can't join if
- Patients having a MSI-H/MMRd tumor are excluded from the study (test done according to standard clinical practice).
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
- Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
- Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
See the full eligibility criteria
- Pegasus trial written informed consent.
- Age ≥ 18 years.
- 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.
- Availability of the original FFPE tumor tissue.
- Availability of plasma collected prior to surgery.
- Acceptance to undergo at least all the interventional liquid biopsies.
- ECOG performance status 0-1.
- Normal organ functions.
- Women with childbearing potential should complete a pregnancy test and be willing to use highly effective contraceptive methods.
- Patients having a MSI-H/MMRd tumor are excluded from the study (test done according to standard clinical practice).
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
- Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
- Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- 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 is required unless mandated by local health authority.
- Has a known history of active TB (Bacillus Tuberculosis).
- 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.
- Had an incomplete diagnostic colonoscopy and/or polyps removal.
- 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).
- Current or recent treatment with another investigational drug or participation in another investigational study.
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- Inadequate contraception (male or female patients) if of childbearing or procreational potential.
- Clinically relevant cardiovascular disease.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.