BridgeMD
Next generation StaR-TREC
EU CTIS ID: 2025-522955-25-00
What this study is testing
The primary objective of this trial is to achieve a sustained clinical complete response rate in patients 1 year after treatment.
- Therapeutic use (Phase IV)
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
- The subject has given their written consent to participate in the trial
- Be 18 years or older
- Have an adenocarcinoma verified tumour within the rectum below 12 cm from anal verge
- Have a tumour stage of TX/T1-3b (regardless of tumour size)
- Have no nodal metastases (NX/N0)
- Have no distant metastases (MX/M0)
You likely can't join if
- Give no informed consent
- Have no residual luminal tumour following endoscopic resection prior to first visit at surgical department
- Have contraindications to radiotherapy including previous pelvic radiotherapy
- Have uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
- Have known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- Have known Gilbert’s disease (hyperbilirubinemia)
See the full eligibility criteria
- The subject has given their written consent to participate in the trial
- Be 18 years or older
- Have an adenocarcinoma verified tumour within the rectum below 12 cm from anal verge
- Have a tumour stage of TX/T1-3b (regardless of tumour size)
- Have no nodal metastases (NX/N0)
- Have no distant metastases (MX/M0)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- For female subjects of childbearing potential: Have a negative pregnancy test within 7 days prior to study entry and Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
- If non-sterilised male with a partner of childbearing potential, must: Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
- Give no informed consent
- Have no residual luminal tumour following endoscopic resection prior to first visit at surgical department
- Have contraindications to radiotherapy including previous pelvic radiotherapy
- Have uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
- Have known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- Have known Gilbert’s disease (hyperbilirubinemia)
- Have been taking coumarin-derivative anticoagulants (e.g. warfarin) that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
- Are taking metronidazole, phenytoin or sorivudine or its chemically related analogues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details)
- Are Pregnant or lactating woman
- Have history of severe and unexpected reactions to fluoropyrimidine therapy
- No biopsy confirmed rectal cancer (adenocarcinoma)
- Have a recurrent rectal cancer
- An age below 18
- Have concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years
- Have unequivocal evidence of metastatic disease (includes respectable metastases)(Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT)
- Have an MRI node positive tumour (≥N1, defined by protocol guidelines) (Patients with equivocal radiological findings that are either classified as NX or N0 are eligible)
- Have MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)
- Have a threatened mesorectal fascia (≤1 mm on MRI or ERUS)
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.