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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Simon Bach
+44 (0)121 414 7671
STAR-TREC@Trials.bham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Can we save the rectum by watchful waiting or transanal surgery following (chemo)radiotherapy versus total mesorectal excision for early rectal cancer?
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Can we save the rectum by watchful waiting or transanal surgery following (chemo)radiotherapy versus total mesorectal excision for early rectal cancer?

Not Recruiting

Open to: All Genders

Age: Adult

Manchester Cardiff Cardiff Manchester Colchester Birmingham Coldfield Leeds Dundee Norwich Bristol Oxford Oxford York Bradford Cambridge Nijmegen Amsterdam Leiden Roermond Zwolle Breda Tilburg Utrecht Eindhoven Amsterdam Leeuwarden Capelle aan den IJssel Amsterdam Amsterdam Amsterdam Deventer Odense C Aarhus

Medical Conditions

Specialty: Cancer, Primary sub-specialty: Colorectal
UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2016 31 Dec 2023

Publications

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29288190 protocol2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32070386/ radiotherapy quality assurance (added 28/06/2021)2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32099912/ rationale behind radiotherapy treatment target volume (added 28/06/2021)2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35114057/ (added 14/11/2022)

Interventional

Intervention Type : Mixed
Intervention Description : Current interventions as of 28/06/2021:Patients will be recruited following informed consent, which will be conducted in accordance with Good Clinical Practice standards, after all baseline assessments are completed and all eligibility criteria have been confirmed. STAR-TREC is a rolling phase II/III study comprising the following components:

Phase II: The STAR-TREC phase II feasibility component is an international, multi-centre, randomised trial, comprising a 1:1:1 randomisation for eligible subjects with a small, clinically localised rectal cancer between: 1. Conventional TME surgery 2. Organ saving utilising long course concurrent chemoradiation 3. Organ saving utilising short course preoperative radiotherapy. The phase II component will be closed once approximately 120 patients are recruited and all necessary approvals for protocol version 4.0 implementing the phase III design are obtained. Target recruitment rates are ≥4 and ≥6 patients randomised per month at 12 and 24 months respectively for total accrual of 120 international cases. Each individual country will attempt to exceed the minimum recruitment required to sustain phase III (UK 75, the Netherlands 75, Denmark 30). If recruitment is on target in year two then consideration will be given to an early application for transition to phase III with a funding application and a formal protocol amendment.

Phase III: International, multi-centre, open-label, rolling phase II/III trial with a partially randomised patient preference design. Patients will choose organ preservation or standard surgery. Those who prefer organ preservation will be randomised 1:1 between: 1. Organ preservation with mesorectal CRT. Capecitabine: 825 mg/m² orally, b.d., on radiotherapy days . Radiotherapy: A dose of 50 Gy applied to the primary tumour and surrounding mesorectum in 25 fractions of 2 Gy, 5 days a week.2. Organ preservation with mesorectal SCRT. A dose of 25 Gy applied to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week. Those who prefer standard surgery or have no preference will undergo standard TME surgery without neoadjuvant radiotherapy treatment.

Phase II and III:For organ-preserving strategies, clinical response to radiotherapy determines the next treatment step. Radiotherapy response is evaluated using clinical exam, endoscopy and MRI. The first assessment at 11-13 weeks (from radiotherapy start) using composite clinical, endoscopic and MRI based assessment will identify a minority of non-responders who should convert to TME surgery. Patients demonstrating a satisfactory radiotherapy response at 11-13 weeks will be reassessed by endoscopy at 16-20 weeks. Re-evaluation at 16-20 weeks determines if the STAR-TREC criteria for complete response (CR) are met. Patients who achieve CR may progress directly to active surveillance. Those who do not fulfil the criteria for CR will progress to excision biopsy with TEM.

Previous interventions:After all eligibility criteria have been confirmed and following informed consent, which will be conducted in accordance with Good Clinical Practice standards, and completion of the baseline assessments, patients will be randomised to one of three groups in a 1:1:1 basis using a computer-generated program at the Birmingham Clinical Trials Units (BCTU).

Group 1: Participants undergo conventional TME surgery. This will encompass both reconstructive and non-reconstructive approaches to rectal resection using the principles of TME surgery. The former includes low anterior resection, the latter abdominoperineal excision or low Hartman’s procedure. Surgeons may use either a laparoscopic, robotic or open approach to surgery. Hybrid approaches (combined laparoscopic and open) are also permitted. The quality of surgery will be measured using a standardised histopathological assessment that grades whether surgery was performed according to the principles of TME.

Group 2: Participants undergo organ using long course concurrent chemoradiation (CRT). This involves concurrent chemoradiotherapy consisting of treatment with capecitabine, administered at a dose of 825 mg/m2 bid on days of radiotherapy treatment (excluding weekend days when patients do not undergo radiotherapy treatment). Capecitabine is taken orally twice a day in equal doses for 5 days per week (normally Monday – Friday), on the days of radiotherapy administration only, throughout the 5 week course of radiotherapy. If radiotherapy is not given (e.g. due to machine maintenance or bank holiday), then capecitabine should not be given that day either. Capecitabine treatment can begin on any day of the week; however, there is normally no capecitabine treatment on Saturday or Sunday, unless radiotherapy is given on one of these days. Patients are asked to take capecitabine with a glass of water each day within 30 minutes after the ingestion of food (ideally after breakfast and evening meals), commencing the morning of the first dose of radiotherapy treatment. If patients have difficulty swallowing tablets, it is possible to dissolve the tablets in approximately 200 ml of lukewarm water. There is no stability data for any form of capecitabine suspension, so this should be done immediately prior to use and the solution swallowed immediately, rinsing to ensure all of the suspension has been ingested. As the solution has a bitter taste, flavouring with a fruit juice or squash (except grapefruit juice) is allowed.

Group 3: Participants undergo organ using short course radiotherapy (SCPRT). This involves a dose of 25Gy, applied, to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week. A total dose of 25 Gy in 5 daily fractions over a total time of 1 week should be delivered, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction.

For participants in group 1, surgical morbidity will be recorded post-operatively until 30 days after surgery. Follow-up after standard TME surgery will differ significantly compared to the organ preserving strategies. Both will include regular clinical follow-up as per usual national practice. Each centre can perform additional visits, endoscopies or imaging as per national protocol or patient/doctors preference. The minimal required follow-up after TME surgery will be at 30-days post-operatively and then 3, 6 12, 24 and 36 months after TME surgery and is detailed in the protocol. CT of chest-abdomen is required in order to have a reliable disease free survival of all patients in this study after 24 months. CT or MRI pelvis is also required in order to have a reliable pelvic recurrence rate of all patients in this study after 24 months. The information routinely recorded in normal clinical notes should be sufficient for completion of the annual follow-up case report forms.

For participants in groups 2 and 3, radiotherapy vwill be administered as per protocol and radiotherapy delivery and toxicities up to 3 weeks after the completion of radiotherapy will be recorded. Follow-up after (chemo)radiotherapy will include regular follow-up as per usual practice. To monitor the need for local excision, radical surgery or watchful waiting, mucosal or lymph node recurrence should be carefully monitored and additional examinations are mandatory as listed below. If patients are treated with radical surgery (TME) the follow-up schedule as described in above for patients in group 1 , ‘Clinical assessments and follow-up after TME surgery’ will be used. In the first year, all organ preserved patients will undergo a MRI and endoscopy every 3 months. CT of chest-abdomen is required in order to have a reliable disease free survival of all patients in this study after 24 months. The information routinely recorded in normal clinical notes should be sufficient for completion of the annual follow-up case report forms. If patients will undergo TME surgery because of incomplete response after (chemo)radiation therapy or in case of recurrence, follow up will be performed at 3, 4.5, 6, 9, 12, 18, 24 and 36 months after (Chemo) Radiation Therapy and specifics are detailed in the protocol.




You can take part if:



You may not be able to take part if:


Current participant exclusion criteria as of 28/06/2021:1. 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 2. Unequivocal evidence of metastatic disease (includes resectable metastases). Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT. 3. MRI node positive (≥N1, defined by protocol guidelines)4. MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines) 5. MRI defined mucinous tumour 6. Mesorectal fascia threatened (≤1 mm on MRI or ERUS) 7. Maximum tumour diameter >40 mm (either measured from everted edges on sagittal MRI or on ERUS)8. Tumour position anterior, above the peritoneal reflection on MRI or EUS 9. No residual luminal tumour following endoscopic resection 10. Contraindications to radiotherapy including previous pelvic radiotherapy 11. Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to randomisation) 12. Known dihydropyrimidine dehydrogenase (DPYD) deficiency 13. Known Gilberts disease (hyperbilirubinaemia) 14. 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 heparin15. Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details)16. Taking metronidazole at study entry17. Pregnant or lactating18. History of severe and unexpected reactions to fluoropyrimidine therapy19. Aged <16 years (UK) or <18 years (other countries)

Previous participant exclusion criteria:1. Unequivocal evidence of metastatic disease (includes resectable metastases) 2. MRI node positive (defined by protocol guidelines) 3. MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines) 4. MRI defined mucinous tumour 5. Mesorectal fascia threatened (< 1 mm on MRI) 6. Maximum tumour diameter > 40mm as measured from everted edges on sagittal MRI 7. Tumour position anterior, above the peritoneal reflection on MRI or EUS 8. No residual luminal tumour following endoscopic resection 9. Contraindications to radiotherapy including previous pelvic radiotherapy 10. Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months prior to randomisation) 11. Known dihydropyrimidine dehydrogenase (DPYD) deficiency 12. Known Gilberts disease (hyperbilirubinaemia) 13. Taking warfarin that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin 14. Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine (see Section 8.4.5 for further details) 15. Pregnant, lactating or pre-menopausal women not using adequate contraception16. Unable or unwilling to provide written informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Manchester University NHS Foundation Trust
    Manchester Royal Infirmary Oxford Road
    Manchester
    M13 9WL
  • Cardiff & Vale Health Board
    University Hospital of Wales Heath Park Way
    Cardiff
    CF14 4XW
  • Velindre NHS Trust
    Velindre Cancer Centre Velindre Rd
    Cardiff
    CF14 2TL
  • The Christie NHS Foundation Trust
    Christie Hospital 27 Palatine Rd
    Manchester
    M20 3JJ
  • East Suffolk and North Essex NHS Foundation Trust
    Colchester Hospital Turner Rd
    Colchester
    CO4 5JL
  • University Hospitals Birmingham NHS Trust
    Queen Elizabeth Hospital Birmingham Mindelsohn Way
    Birmingham
    B15 2TH
  • University Hospitals Birmingham NHS Trust
    Good Hope Hospital Rectory Rd Sutton
    Coldfield
    B75 7RR
  • The Leeds Teaching Hospitals NHS Trust
    St James's University Hospital Beckett St Harehills
    Leeds
    LS9 7TF
  • Tayside Health Board
    Ninewells Hospital James Arrott Dr
    Dundee
    DD2 1SG
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Norfolk and Norwich University Hospital Colney Ln
    Norwich
    NR4 7UY
  • North Bristol NHS Trust
    Southmead Hospital Southmead Rd
    Bristol
    BS10 5NB
  • Oxford University Hospitals NHS Foundation Trust
    Churchill Hospital Old Rd Headington
    Oxford
    OX3 7LE
  • Oxford University Hospitals NHS Foundation Trust
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • York and Scarborough Teaching Hospitals NHS Foundation Trust
    York Hospital Wigginton Rd Clifton
    York
    YO31 8HE
  • Bradford Teaching Hospitals NHS Foundation Trust
    Bradford Royal Infirmary Duckworth Ln
    Bradford
    BD9 6RJ
  • Cambridge University Hospitals NHS Foundation Trust
    Addenbrooke's Hospital Hills Rd
    Cambridge
    CB2 0QQ
  • Radboud University Medical Center
    Geert Grooteplein Zuid 10
    Nijmegen
    6525 GA
  • Antoni van Leeuwenhoek Ziekenhuis / The Netherlands Cancer Institute
    Plesmanlaan 121
    Amsterdam
    1066 CX
  • Leiden University Medical Center
    Albinusdreef 2
    Leiden
    2333 ZA
  • Laurentius Ziekenhuis
    Monseigneur Driessenstraat 6
    Roermond
    6043 CV
  • Isala Ziekenhuis
    Dokter Stolteweg 92
    Zwolle
    8025 AV
  • Amphia Ziekenhuis
    Molengracht 21
    Breda
    4818 CK
  • Elisabeth Tweesteden Ziekenhuis
    Doctor Deelenlaan 5
    Tilburg
    5042 AD
  • Diakonessenhuis Utrecht
    Bosboomstraat 1
    Utrecht
    3582 KE
  • Catharina Ziekenhuis
    Michelangelolaan 2
    Eindhoven
    5623 EJ
  • Amsterdam UMC (locatie VUmc)
    De Boelelaan 1117 1118
    Amsterdam
    1081 HV
  • Medisch Centrum Leeuwarden
    Henri Dunantweg 2
    Leeuwarden
    8934 AD
  • IJsselland Ziekenhuis
    Prins Constantijnweg 2
    Capelle aan den IJssel
    2906 ZC
  • OLVG
    Oosterpark
    Amsterdam
    91091 AC
  • OLVG
    Jan Tooropstraat 164
    Amsterdam
    1061 AE
  • OLVG
    Spuistraat 239a
    Amsterdam
    1012 VP
  • Deventer Ziekenhuis
    Nico Bolkesteinlaan 75
    Deventer
    7416 SE
  • Odense University Hospital
    Søndre Blvd. 29
    Odense C
    5000
  • Aarhus University Hospital
    Palle Juul-Jensens Blvd. 161
    Aarhus
    8200

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Mr Simon Bach
+44 (0)121 414 7671
STAR-TREC@Trials.bham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Birmingham and funded by Cancer Research UK.



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Read full details for Trial ID: ISRCTN14240288

Or CPMS 31203

Last updated 14 November 2022

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