BridgeMD
Study evaluating the tailored management of locally-advanced rectal carcinoma
EU CTIS ID: 2024-511609-44-00
What this study is testing
Phase II: To assess, for good responders patients to neoadjuvant CT (NACT), a de-escalation treatment strategy respecting a satisfactory R0 resection rate (90%). Phase III: To assess for good responders patients to NACT a de-escalation treatment strategy respecting the actual 3 years DFS in a non-inferiority trial.
- Phase II and Phase III (Integrated)
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
- Patient with tumoral regression ≥ 60% and CRM ≥ 1mm,
- No unequivocal evidence on CT-Scan of established metastatic disease
- General condition considered suitable for radical pelvic surgery and a systemic therapy with Capecitabine
- Adequate hematologic, hepatic, renal and ionogram function assessed within 7 days prior to study treatment
You likely can't join if
- Patient with a history of pelvic radiotherapy,
- Contraindication to chemotherapy and/or radiotherapy,
- Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL),
- Known hypersensitivity to Capecitabine drug, study drug classes, or any constituent of the products,
- Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum β-hCG) documented 72 hours prior to inclusion,
- Patient treated with an investigational drug within the last 30 days,
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, 65+ years, 18-64 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.