BridgeMD
A personalised approach based on blood and tumor characteristics to guide the post-surgical clinical path of patients with operable locoregional colon cancer
EU CTIS ID: 2023-509851-15-00
What this study is testing
To prove that a personalized ctDNA-guided genomic-based targeted treatment strategy can improve the clinical outcome of Stage III and High-Risk Stage II CC patients as respect to a conventional adjuvant chemotherapy approach.
- Therapeutic confirmatory (Phase III)
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
- SAGITTARIUS trial written informed consent.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of operable stage III and High-Risk stage II colon cancer located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
- Availability of the primary tumor tissue FFPE.
- ECOG performance status 0-1.
- Normal organ functions (as defined in section 8.3 of the Protocol).
You likely can't join if
- 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.
- 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).
- 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.
- Current or recent treatment with another investigational drug or participation in another investigational study
See the full eligibility criteria
- SAGITTARIUS trial written informed consent.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of operable stage III and High-Risk stage II colon cancer located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
- Availability of the primary tumor tissue FFPE.
- ECOG performance status 0-1.
- Normal organ functions (as defined in section 8.3 of the Protocol).
- Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.
- 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.
- 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).
- 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.
- Current or recent treatment with another investigational drug or participation in another investigational study
- Clinically relevant cardiovascular disease.
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease.
- Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications.
- Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- Prior neoadjuvant treatment administered before surgery.
- 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
- Has a known history of active TB (Bacillus Tuberculosis).
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.