Trial design

STAR-TREC is an international, multi-centre, randomised, phase II feasibility study comprising a 1:1:1 randomisation for eligible subjects with a small, clinically localised rectal cancer between;

  • ARM A: Conventional TME surgery
  • ARM B: Organ saving utilising long course concurrent chemoradiation
  • ARM C: Organ saving utilising short course preoperative radiotherapy

 A total of 120 patients will be randomised over 2 years.

Aim of phase II study

Primary outcome measure
  • Recruitment rate
Core secondary endpoints
  • Procurement of STAR-TREC funding by one international partner
  • Opening of STAR-TREC by one international partner
  • Efficacy of organ preserving treatment arm 
Other secondary endpoints pertinent to the future phase III study
  • Accuracy of MRI in predicting STAR-TREC eligibility
  • 30-day mortality
  • 6 month mortality
  • Surgical morbidity
  • Rate of tumour recurrence or regrowth within the bowel wall (experimental arm)
  • Rate of tumour recurrence within the mesorectum (experimental arm)
  • Rate of distant metastases
  • Pelvic failure rate
  • Bowel, bladder and sexual dysfunction
  • Proportion of patients with / without a stoma at one year
  • Histopathological assessment of tumour down-staging following radiotherapy
  • Proportion of patients identified by clinical and MRI assessment as suitable for active monitoring
  • Conversion rates from organ saving to radical surgery
  • Disease free survival
  • Quality of life
  • Overall survival


STAR-TREC is open at hospitals in the UK, Netherlands and Denmark.


 Inclusion Criteria

  • Biopsy proven adenocarcinoma of the rectum
  • mriT1-3bN0 (with ≤5mm of mesorectal invasion) rectal tumour or endorectal ultrasound defined retal cancer uT1-uT3b
  • MDT determines that all of the following treatment options are feasible (a) TMG surgery, (b) CRT, (c) SCPRT, (d) TEM
  • Patients with equivocal radiological lesions e.g. mesorectal, retroperitoneal, liver, lung are eligible if agreed by MDT
  • Aged 16 or over in UK (18 in Netherlands and Denmark)
  • (Pre-treatment) Estimated creatinine clearance >50mls/min
  • (Pre-treatment) Absolute neutrophil count >1.5x109/l; platelets >100 x 109/L
  • (Pre-treatment) Serum transaminase <3 x Upper Limit Normal/l (ULN)
  • (Pre-treatment) Bilirubin <1.5 x ULN
  • ECOG performance status 0-1
  • (If female and of childbearing potential) 1. Negative pregnancy test ≤72hours prior to initiating study treatment; 2. Agree to avoid pregnancy during and for 6 months after study treatment
  • (If male and with a partner of childbearing potential) Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
  • Able and willing to provide written informed consent

 Exclusion Criteria

  • Unequivocal evidence of metastatic disease (includes resectable metastases)
  • MRI node positive
  • MRI extramural vascular invasion (mriEMVI) positive
  • MRI defined mucinous tumour
  • Mesorectal fascia threatened (≤1mm on MRI)
  • Maximum tumour diameter >40mm as measured from everted edges on sagittal MRI
  • Tumour position anterior, above the peritoneal reflection on MRI or EUS
  • No residual luminal tumour following endoscopic resection
  • Contraindications to radiotherapy including previous pelvic resection
  • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months prior to randomisation)
  • Known dihydropyrimidine dehydrogenase (DYPD) deficiency
  • Known Gilberts disease (hyperbilirubinaemia)
  • Taking warfarin that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
  • Taking phenytoin or sorivudine or its chemically related analogues, such as brivudine (more details in protocol)
  • Patients currently taking metronidazole
  • Pregnant, lactating or pre-menopausal women not using adequate contraception
  • History of severe and unexpected reactions to fluoropyrimidine therapy
  • Unable or unwilling to provide written informed consent

Get Involved

Register now

Registering your interest and confirming participation in the STAR-TREC can be completed in three simple steps:

  1. Discuss the study locally with the Surgeon, Radiologists, Pathologist, Oncologists and Research nurses.
  2. Complete the STAR-TREC Trial Site Feasibility/Assessment & Registration form. 
  3. Send the completed Site Feasibility/Assessment & Registration form to the STAR-TREC Study office along with:
    • CV and GCP certificate of the potential Principal Investigator.
    • CV and GCP certificate of all those listed on the Site Feasibility/Assessment & Registration form.
    • CV and GCP certificate of all those listed on the Site Feasibility/Assessment & Registration form.