2025-522955-25-00Not yet recruitingPhase 4

Next generation StaR-TREC

Next Generation StaR TREC - Save the rectum by watchful waiting after (chemo)Radiotherapy or Total mesorectal excision for early REctal Cancer?

Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 May 2026

Brief summary (registry, in English)

The primary objective of this trial is to achieve a sustained clinical complete response rate in patients 1 year after treatment.

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early rectal cancer (adenocarcinoma) in the lower rectum that has not spread to lymph nodes or other organs.

Age: 18 years or older
Sex: All sexes can join.
Disease stage: Adenocarcinoma in the rectum, below 12 cm from the anal verge. Tumour stage TX/T1-3b, any size. No spread to lymph nodes (NX/N0). No spread to other organs (MX/M0).
Earlier treatment: A tumour must still remain after endoscopic removal. No previous pelvic radiotherapy. No fluoropyrimidine drug reaction that was severe and unexpected.
Biomarker or test result: Known complete DPYD deficiency means a person cannot join. No other marker is asked for.

Read by machine on 9 Nov 2026.

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

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 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

Have known Gilbert’s disease (hyperbilirubinemia)
Have history of severe and unexpected reactions to fluoropyrimidine therapy
No biopsy confirmed rectal cancer (adenocarcinoma)
Have a recurrent rectal cancer
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)

Give no informed consent
Have known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
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 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 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Sahlgrenska University Hospital-Vaestra Goetalandsregionen	Gothenburg	Sweden	Not yet recruiting
Region Skane Skanes Universitetssjukhus	Malmo	Sweden	Not yet recruiting
Soedersjukhuset AB	Stockholm	Sweden	Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.