Can we save the rectum by watchful waiting or local surgery following (chemo)Radiotherapy versus radical surgery for early rectal Cancer?

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000862-49-NL

Enrollment

120

Registered

2016-05-19

Start date

2016-08-22

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early rectal cancer

Interventions

Trade Name: Capecitabine Product Name: Capecitabine Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Capecitabine CAS Number: N/A Current Sponsor code: N/A Concentration unit: mg/m2 millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Biopsy proven adenocarcinoma of the rectum • mriT1-3bN0 (with =5mm of mesorectal invasion) rectal tumour or endorectal ultrasound defined rectal cancer uT1-uT3b (optional: in centres where high quality ERUS is available and patient unable to tolerate MRI) • MDT determines that all of the following treatment options are feasible: (a) TME 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 or over in the Netherlands and Denmark). • Estimated creatinine clearance >50 mls/min • Absolute neutrophil count >1.5x109/l; platelets >100 x 109/L • Serum transaminase =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: • Unequivocal evidence of metastatic disease (includes resectable metastases) • MRI node positive (defined by protocol guidelines) • MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines) • MRI defined mucinous tumour • Mesorectal fascia threatened ( 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 radiotherapy • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months prior to randomisation) • Known dihydropyrimidine dehydrogenase (DPYD) 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 anologues, such as brivudine (see Section 8.4.5 for further details) • Pregnant, lactating or pre-menopausal women not using adequate contraception. • Unable or unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the STAR-TREC study is to assess the feasibility of successfully recruiting to a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using (chemo)radiotherapy followed by selective transanal microsurgery. STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate patient recruitment from 2 per month, as attained in the previous TREC study, to 6 per month over a two-year period. This would demonstrate deliverability of a phase III study incorporating 400 patients to evaluate differences in pelvic relapse rates between organ saving and standard surgery. Randomising 70-80 patients per year in phase III would achieve this target in 4 years (including patients treated in phase II). PHASE II PRIMARY ENDPOINTS 1. Year 1: randomise at least 4 cases per month internationally (n=48) 2. Year 2: randomise at least 6 cases per month internationally (n=72);Secondary Objective: Secondary Objectives: 1. Year 1: Can one international partner procure independent STAR-TREC funding? Successful international collaboration will be necessary to deliver a future phase III study of 400 patients. 2. Year 1: Can one international partner open the STAR-TREC study to recruitment? 3. Efficacy of organ preserving treatment arms on completion of phase II study: Is the organ saving rate > 50% at 12 months (following randomisation) in the experimental arms ? This figure is intended as a guide to both the STAR-TREC DMEC and any phase III peer review. 4. We expect that the actual organ saving rate would lie between 60-70%. Using a target of 50% in phase II will allow for the relatively small sample size. We consider that this metric of efficacy would be suitable for early publication (with toxicity data) as it does not constitute a primary outcome for phase III. 5. Proportion of patients undergoing primary TME surgery (control-group) accurately staged by MRI and s;Primary end point(s): Pr	—

Measure

Time frame

Main Objective: The aim of the STAR-TREC study is to assess the feasibility of successfully recruiting to a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using (chemo)radiotherapy followed by selective transanal microsurgery. STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate patient recruitment from 2 per month, as attained in the previous TREC study, to 6 per month over a two-year period. This would demonstrate deliverability of a phase III study incorporating 400 patients to evaluate differences in pelvic relapse rates between organ saving and standard surgery. Randomising 70-80 patients per year in phase III would achieve this target in 4 years (including patients treated in phase II). PHASE II PRIMARY ENDPOINTS 1. Year 1: randomise at least 4 cases per month internationally (n=48) 2. Year 2: randomise at least 6 cases per month internationally (n=72);Secondary Objective: Secondary Objectives: 1. Year 1: Can one international partner procure independent STAR-TREC funding? Successful international collaboration will be necessary to deliver a future phase III study of 400 patients. 2. Year 1: Can one international partner open the STAR-TREC study to recruitment? 3. Efficacy of organ preserving treatment arms on completion of phase II study: Is the organ saving rate > 50% at 12 months (following randomisation) in the experimental arms ? This figure is intended as a guide to both the STAR-TREC DMEC and any phase III peer review. 4. We expect that the actual organ saving rate would lie between 60-70%. Using a target of 50% in phase II will allow for the relatively small sample size. We consider that this metric of efficacy would be suitable for early publication (with toxicity data) as it does not constitute a primary outcome for phase III. 5. Proportion of patients undergoing primary TME surgery (control-group) accurately staged by MRI and s;Primary end point(s): Pr

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Secondary

Measure	Time frame
Secondary end point(s): The core secondary endpoints of this phase II trial are: • Procurement of STAR-TREC funding by one international partner • Opening of STAR-TREC by one international partner • Efficacy of organ preserving treatment arm on completion of phase II study: Is an organ saving rate > 50% at 12 months (following randomisation) achieved in the experimental arms? Additional outcome measures pertinent to a future phase III study examining the safety and efficacy of organ saving versus standard surgery will also be collected. • SAFETY o Accuracy of MRI in predicting STAR-TREC eligibility o 30-day mortality o 6 month mortality o Surgical morbidity o Rate of tumour recurrence or regrowth within the bowel wall (experimental arm) o Rate of tumour recurrence within the mesorectum (experimental arm) o Rate of distant metastases o Pelvic failure rate: expressed as a sum of the following (i) unresectable pelvic tumour, (ii) cases requiring beyond TME surgery or (iii) tumour recurrence or regrowth =1mm from the circumferential surgical margin after TME surgery. o Bowel, bladder and sexual dysfunction (measured by EORTC QLQ CR29 & C30, LARS score and ICIQ-MLUTS) • EFFICACY o Proportion of patients with/ without a stoma at one year o Histopathological assessment of tumour down-staging following radiotherapy according to depth of tumour invasion and the incidence of other high-risk features in comparison to non-irradiated (control) group. o Proportion of patients identified by clinical and MRI assessment as suitable for active monitoring o Conversion rates from organ saving to radical surgery o Disease free survival o Quality of life (measured by EORTC QLQ CR29 & C30, EuroQol EQ-5D, LARS score and ICIQ-MLUTS) o Overall survival ;Timepoint(s) of evaluation of this end point: The core secondary endpoints of this phase II trial are: • Procurement of STAR-TREC funding by one international partner • Opening of STAR-TREC by one internatio	—

Measure

Time frame

Secondary end point(s): The core secondary endpoints of this phase II trial are: • Procurement of STAR-TREC funding by one international partner • Opening of STAR-TREC by one international partner • Efficacy of organ preserving treatment arm on completion of phase II study: Is an organ saving rate > 50% at 12 months (following randomisation) achieved in the experimental arms? Additional outcome measures pertinent to a future phase III study examining the safety and efficacy of organ saving versus standard surgery will also be collected. • SAFETY o Accuracy of MRI in predicting STAR-TREC eligibility o 30-day mortality o 6 month mortality o Surgical morbidity o Rate of tumour recurrence or regrowth within the bowel wall (experimental arm) o Rate of tumour recurrence within the mesorectum (experimental arm) o Rate of distant metastases o Pelvic failure rate: expressed as a sum of the following (i) unresectable pelvic tumour, (ii) cases requiring beyond TME surgery or (iii) tumour recurrence or regrowth =1mm from the circumferential surgical margin after TME surgery. o Bowel, bladder and sexual dysfunction (measured by EORTC QLQ CR29 & C30, LARS score and ICIQ-MLUTS) • EFFICACY o Proportion of patients with/ without a stoma at one year o Histopathological assessment of tumour down-staging following radiotherapy according to depth of tumour invasion and the incidence of other high-risk features in comparison to non-irradiated (control) group. o Proportion of patients identified by clinical and MRI assessment as suitable for active monitoring o Conversion rates from organ saving to radical surgery o Disease free survival o Quality of life (measured by EORTC QLQ CR29 & C30, EuroQol EQ-5D, LARS score and ICIQ-MLUTS) o Overall survival ;Timepoint(s) of evaluation of this end point: The core secondary endpoints of this phase II trial are: • Procurement of STAR-TREC funding by one international partner • Opening of STAR-TREC by one internatio

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Countries

Belgium, Denmark, Netherlands, Sweden, United Kingdom

Contacts

Public ContactMr Simon Bach

The University of Birmingham

s.p.bach@bham.ac.uk01216978449

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026