STAR-TReC

Trial Info

Status: Open

Specialty: Colorectal

Date Opened: 08/04/2022

Planned Close Date: 01/12/2023

Sponsor: Cancer Research UK Clinical Trials Unit

Principal Investigator: Mr Alan Beveridge

Study Title: Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?

Trial Description

STAR-TREC is an international, multi-centre, open-label, rolling phase II/III study.

Phase II feasibility component:

Randomised trial, comprising a 1:1:1 randomisation for eligible subjects with a small, clinically localised rectal cancer between:

(a) Conventional TME surgery; (b) “Organ saving” utilising long course concurrent chemoradiation; (c) “Organ saving” utilising short course preoperative radiotherapy.

The phase II component closed in 2020 once the target of 120 patients were recruited and all necessary approvals for protocol version 4.0 implementing the phase III design were obtained.

Phase III component:

A partially randomised patient preference design trial with patients choosing organ preservation or standard surgery.

Those who prefer organ preservation will be randomised 1:1 between (i) “Organ saving” with mesorectal Chemoradiotherapy (CRT) versus (ii) “Organ saving” with mesorectal Short Course Radiotherapy (SCRT).

Those who prefer standard surgery or have no preference will undergo standard Total Mesorectal Excision (TME) surgery without neoadjuvant radiotherapy treatment.

The aim of the STAR-TREC study is to find the best way of treating a small rectal cancer. STAR-TREC will compare three different approaches. The “gold standard” treatment involves a large operation (called radical surgery) to remove the whole rectum. Two new approaches are designed to avoid the need for major surgery, we call these the “organ saving” treatments. These organ saving treatments use different types of radiotherapy to try and shrink the cancer as much as possible. How much the cancer shrinks will guide what happens next. In some patients the cancer disappears completely after radiotherapy and no further treatment is needed. In others a small lump remains after radiotherapy, and this is then removed by ‘keyhole’ surgery through the anus. Only the part of bowel wall affected by cancer is removed, most of the rectum and the anus are left alone. Finally, if the cancer does not shrink sufficiently we recommend that the patient has radical surgery to remove the rectum. While we believe that these new approaches are likely to have fewer side effects than the “gold standard” treatment, not many patients have received organ saving treatment, so we do not know if it will be as effective at curing cancer. In addition, some patients may have organ saving treatment and still need major surgery at some point. We will learn more about the new organ saving tre

Inclusion Criteria

- Biopsy proven adenocarcinoma of the rectum

- MRI-defined ≤T3b (with ≤5mm of mesorectal invasion) rectal tumour or endorectal ultrasound-defined ≤uT3b rectal cancer (optional: in centres where high quality endorectal ultrasound (ERUS) is available or patient unable to tolerate MRI)

- MDT determines that all of the following treatment options are reasonable and feasible: (a) TME surgery, (b) CRT (c) SCRT d) TEM.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- For patients choosing organ preservation only:

• If female and of childbearing potential, must:

> Have a negative pregnancy test within 7 days prior to study entry

> Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment

• If non-sterilised male 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

- Patient able and willing to provide written informed consent for the study

Exclusion Criteria

• 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

• 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

• MRI node positive (≥N1, defined by protocol guidelines)

Patients with equivocal radiological findings that are either classified as NX or N0 are eligible

• MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)

• MRI defined mucinous tumour

• Mesorectal fascia threatened (≤1 mm on MRI or ERUS)

• Maximum tumour diameter > 40mm (either measured from everted edges on sagittal MRI or on ERUS)

• Tumour position anterior, above the peritoneal reflection on MRI or EUS

• No residual luminal tumour following endoscopic resection

• Contraindications to radiotherapy including previous pelvic radiotherapy

• Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)

• Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency

• Known Gilbert’s disease (hyperbilirubinaemia)

• 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

• Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine, within 4 weeks of trial entry

• Taking metronidazole at study entry

• Pregnant or lactating women

• History of severe and unexpected reactions to fluoropyrimidine therapy

• Age <16 years (UK), <18 years (other countries)

Contacts

Lead Research Nurse: Rashmi Madan (x2136) Rashmi.Madan@LTHTR.nhs.uk

Clinical Trials Administrator : Yecora Lecanda-Swarbrick (x3766)

Link to EDGE

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