Next generation StaR-TREC
Key facts
- Where
- Gothenburg, Malmo és Stockholm, SvédországSee the 3 sites
- Phase
- 4. fázis
Where in Svédország
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGothenburg, SvédországToborzás még nem indult
- Region Skane Skanes UniversitetssjukhusMalmo, SvédországToborzás még nem indult
- Soedersjukhuset ABStockholm, SvédországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vaestra Goetalandsregionen
- Trial code
- EU 2025-522955-25-00
- Record updated
- 2026. május 6.
- Original description
The primary objective of this trial is to achieve a sustained clinical complete response rate in patients 1 year after treatment.Read full original descriptionShow less
Next Generation StaR TREC - Save the rectum by watchful waiting after (chemo)Radiotherapy or Total mesorectal excision for early REctal Cancer?
The primary objective of this trial is to achieve a sustained clinical complete response rate in patients 1 year after treatment.
Inclusion: 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.
Exclusion: 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); An age below 18; 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).