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STAR-TREC: Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?
EU CTIS ID: 2024-516106-31-00
What this study is testing
The phase II component will assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using (chemo)radiotherapy followed by selective transanal microsurgery. The STAR-TREC phase III study will evaluate whether a CRT or SCRT organ preservation strategy leads to higher organ preservation rates and should become first line treatment for early rectal cancer. This objective can be divided into two main questions: a) Determine the optimal radiation schedule to achieve the highest rate of organ preservation b) Determine the optimal radiation schedule to achieve the best quality of life after organ preservation
- 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
- Biopsy proven adenocarcinoma of the rectum
- Magnetic Resonance Imaging (MRI)- or Endorectal Ultrasound (ERUS)-staged TX/T1-3b, NX/N0, MX/M0 rectal tumour
- MDT determines that the following treatment options are all reasonable and feasible: (a) TME surgery, (b) CRT, (c) SCRT and (d) Transanal Endoscopic Microsurgery (TEM)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Willing and able to consent
You likely can't join if
- 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
- Definite evidence of regional or distant metastases (M1) in opinion of MDT
- Uncontrolled cardiorespiratory comorbidity (inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
- Known complete Dihydropyrimidine Dehydrogenase deficiency
- Known Gilbert’s disease
- Taking coumarin-derivative oral anticoagulants that cannot be stopped or substituted by low molecular weight heparin
See the full eligibility criteria
- Biopsy proven adenocarcinoma of the rectum
- Magnetic Resonance Imaging (MRI)- or Endorectal Ultrasound (ERUS)-staged TX/T1-3b, NX/N0, MX/M0 rectal tumour
- MDT determines that the following treatment options are all reasonable and feasible: (a) TME surgery, (b) CRT, (c) SCRT and (d) Transanal Endoscopic Microsurgery (TEM)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Willing and able to consent
- 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
- Definite evidence of regional or distant metastases (M1) in opinion of MDT
- Uncontrolled cardiorespiratory comorbidity (inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
- Known complete Dihydropyrimidine Dehydrogenase deficiency
- Known Gilbert’s disease
- Taking coumarin-derivative oral anticoagulants that cannot be stopped or substituted by low molecular weight heparin
- Taking metronidazole, phenytoin, sorivudine or its analogues, such as brivudine
- Women who are pregnant or lactating
- Age <16 years (UK), <18 years (other countries)
- MRI node positive (≥N1, defined by protocol guidelines)
- MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines)
- MRI defined mucinous tumour
- Mesorectal fascia threatened by tumour (≤ 1mm on MRI or ERUS)
- Maximum tumour diameter >40mm (either measured from everted edges on sagittal MRI or ERUS examination)
- Anterior tumour location above the peritoneal reflection on MRI or ERUS
- No residual luminal tumour following endoscopic mucosal resection
- Prior pelvic radiotherapy
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.