Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer? (STAR-TREC)

June 24, 2026 updated by: University of Birmingham

STAR-TREC: Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?

Bowel cancer is the second most common tumour with 41 000 new cases diagnosed annually in the UK, 447 000 across Europe and 1.36 million worldwide; of which one third are located in the rectum. Standard primary radical Total Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in approximately 10% of cases while many more patients have a temporary stoma, some of which are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic tumours, may not be the optimal method of treatment for early screen-detected tumours and an organ preserving strategy may generate significantly less morbidity without substantially compromising oncological outcomes.

STAR-TREC is a rolling phase II/III study. Phase II aimed to assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus two contrasting organ saving treatments followed by selective transanal microsurgery. Phase III will evaluate two contrasting organ preservation strategies in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Phase II component of STAR-TREC (now completed) was a randomised, three arm (1:1:1) study using the following arms:

  1. Standard TME surgery (control)

  2. Organ saving treatments using:

    1. Long course concurrent chemoradiation:

      • 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. Short course radiotherapy:

      • A dose of 25 Gy applied to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week.

The phase III component of STAR_TREC is now open and has a partially randomised patient preference design where patients choose between organ saving treatment or standard surgery.

Those who prefer organ preservation will undergo randomisation 1:1 between:

  1. Long course concurrent chemoradiation (as described above)
  2. Short course radiotherapy (as described above)

Those who prefer standard surgery or have no preference, will undergo standard TME surgery without neoadjuvant radiotherapy treatment.

For organ-preserving strategies in phase II and III, 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 transanal endoscopic microsurgery (TEM).

The phase II component of the study aimed to evaluate the feasibility of accelerating patient recruitment from 2 per month, as attained in the previous TREC study, to 6 per month internationally over a two-year period.

The STAR-TREC phase III study will evaluate whether a CRT or SCRT organ preservation strategy leads to higher organ preservation rates and should become first line treatment for early rectal cancer.

This objective can be divided into two main questions:

  1. Determine the optimal radiation schedule to achieve the highest rate of organ preservation
  2. Determine the optimal radiation schedule to achieve the best quality of life after organ preservation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
380

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • University Hospital UZ Leuven
  • Denmark
      • Odense, Denmark
        • Odense University Hospital
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Center
  • Sweden
      • Stockholm, Sweden
        • Region Stockholm, Onkologkliniken Södersjukhuset AB
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

    --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 (see Section 8.3.5 for further details)
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard TME surgery
Radical total mesorectal excision
Procedure: Standard TME surgery
Total mesorectal excision
Experimental: Long course concurrent chemoradiation
Capecitabine: 825 mg/m² orally, b.i.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.
Drug: Long course concurrent chemoradiation with capecitabine and radiotherapy
Capecitabine 825 mg/m² orally, b.i.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.
Other Names:
  • Xeloda is the brand name for capecitabine
Experimental: Short course radiotherapy
A dose of 25Gy, applied, to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week.
Radiation: Short course radiotherapy
A dose of 25Gy, applied, to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase II (Feasibility study) Primary Outcome: Recruitment Rate
Time Frame: 24 Months
Measured at 12 and 24 months. 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.
24 Months
Phase III Primary Outcome: Organ Preservation
Time Frame: 30 Months from start day of (chemo)radiotherapy treatment.
The primary endpoint of the STAR-TREC phase III study is the proportion of patients with successful organ preservation at 30 months from the start day of (chemo)radiotherapy treatment. This endpoint will be assessed for patients who prefer organ preservation and is defined as an in-situ rectum (includes patients subject to transanal local resection), no defunctioning stoma and an absence of active loco-regional cancer failure. The expected incidence of this outcome is approximately 60%.
30 Months from start day of (chemo)radiotherapy treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase II (Feasibility study): Core Endpoint - Funding
Time Frame: 12 Months
Incidence of procurement of funding by one STAR-TREC international partner
12 Months
Phase II (Feasibility study): Core Endpoint - International Recruitment
Time Frame: 12 Months
Incidence of opening of STAR-TREC by one international partner
12 Months
Phase II (Feasibility study): Core Endpoint - Efficacy
Time Frame: 12 Months
Efficacy of organ preserving treatment arm on completion of phase II study: Is the organ saving rate more than 50% of patients with early stage rectal cancer at 12 months (following randomisation) achieved in the experimental arms? [Name of Measurement: Rate of organ saving >50% at 12 months; Unit of Measurement: no record of radical surgery at 12 months]
12 Months
Phase II: Safety- Accuracy of MRI in predicting STAR-TREC eligibility
Time Frame: 24 Months

MRI

- Accuracy of MRI in predicting STAR-TREC eligibility (We will report the accuracy of MRI based patient selection according to each national standard, compared to the reference standard of post-operative histological staging. STAR-TREC will help develop international consensus in MRI reporting of mesorectal lymph node involvement by rectal cancer)
24 Months
Phase II: Safety - 30 day Mortality
Time Frame: 30 days
- Mortality
30 days
Phase II: Safety - 6 month Mortality
Time Frame: 6 Months
- Mortality
6 Months
Phase II: Safety - Surgical Morbidity
Time Frame: 36 Months
- Surgical morbidity
36 Months
Phase II: Safety - Tumour Recurrence/ Regrowth within Bowel Wall
Time Frame: 36 Months
- Rate of tumour recurrence or regrowth within the bowel wall (experimental arm)
36 Months
Phase II: Safety - Tumour Recurrence within Mesorectum
Time Frame: 36 Months
- Rate of tumour recurrence within the mesorectum (experimental arm)
36 Months
Phase II: Safety - Distant Metastasis
Time Frame: 36 Months
- Rate of distant metastases
36 Months
Phase II: Safety - Pelvic Failure
Time Frame: 36 Months
- 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.
36 Months
Phase II: Safety - Bowel
Time Frame: 36 Months
Bowel dysfunction measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
36 Months
Phase II: Safety - Bladder
Time Frame: 36 Months
Bladder dysfunction measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
36 Months
Phase II: Safety - Sexual dysfunction
Time Frame: 36 Months
Sexual dysfunction measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
36 Months
Phase II: Efficacy - Stoma
Time Frame: 24 Months

Additional outcome measures pertinent to the phase III study examining the efficacy of organ saving versus standard surgery will also be collected:

- Proportion of patients with/ without a stoma at 30 days and one year
24 Months
Phase II: Efficacy - Tumour Down-staging
Time Frame: 4.5 Months
- 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
4.5 Months
Phase II: Efficacy - Active Monitoring
Time Frame: 4.5 Months
- Proportion of patients identified by clinical and MRI assessment as suitable for active monitoring
4.5 Months
Phase II: Efficacy - Conversion Rate
Time Frame: 36 Months
- Conversion rates from organ saving to radical surgery
36 Months
Phase II: Efficacy - Disease Survival
Time Frame: 36 Months
- Disease free survival
36 Months
Phase II: Efficacy - Health-related Quality of Life score
Time Frame: 3 months
Quality of life measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
3 months
Phase II: Efficacy - Health-related Quality of Life score
Time Frame: 12 Months
Quality of life measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
12 Months
Phase II: Efficacy - Health-related Quality of Life score
Time Frame: 24 Months
Quality of life measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
24 Months
Phase II: Efficacy - Health-related Quality of Life score
Time Frame: 36 Months
Quality of life measured by EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] & C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items], LARS score [The Low Anterior Resection Syndrome score], and ICIQ-MLUTS/ICIQ-FLUTS [International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms Module]. Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomisation will be compared to baseline scores.
36 Months
Phase II: Efficacy - Overall Survival
Time Frame: 36 Months
- Overall survival
36 Months
Phase III: For the randomised comparison between organ-preserving strategies
Time Frame: 30 days from start day of (chemo)radiotherapy treatment.
Clinician-reported acute treatment related toxicity up to 30 days following completion of (chemo)radiotherapy
30 days from start day of (chemo)radiotherapy treatment.
Phase III: Complete Response *For the randomised comparison between organ-preserving strategies
Time Frame: 30 months
Proportion of patients with Complete Response to (chemo)radiation therapy
30 months
Phase III: For the randomised comparison between organ-preserving strategies - Local Excision
Time Frame: 20 weeks
Proportion of patients undergoing transanal local excision
20 weeks
Phase III: For the randomised comparison between organ-preserving strategies - Organ Loss
Time Frame: Defined as the length of time from the start date of trial treatment until TME surgery
Time to event of organ loss assessed for patients who prefer organ preservation
Defined as the length of time from the start date of trial treatment until TME surgery
Phase III: For the randomised comparison between organ-preserving strategies - Non-Regrowth
Time Frame: 36 months
Non-regrowth pelvic tumour control to 36 months; defined as the length of time from the start date of trial treatment until death (any cause) or development of unequivocal pelvic recurrence but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery
36 months
Phase III: For the randomised comparison between organ-preserving strategies - Metastasis Free Survival
Time Frame: 36 months
Metastasis free survival to 36 months; defined as the length of time from the start date of trial treatment until death (any cause) or detection of distant metastasis
36 months
Phase III: For the randomised comparison between organ-preserving strategies - Non-regrowth Disease Free Survival
Time Frame: 36 months
Non-regrowth -disease free survival to 36 months; defined as the length of time from the start of trial treatment until death (any cause), detection of local pelvic recurrence or distant metastasis but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery
36 months
Phase III: For the randomised comparison between organ-preserving strategies - Overall Survival
Time Frame: 60 months
Overall survival to 60 months defined as the length of time from the start date of trial treatment until death (any cause)
60 months
Phase III: For analyses incorporating the non-randomised standard surgery comparator - Toxicity
Time Frame: 30 days
Clinician-reported acute treatment related toxicity up to 30 days following completion of (chemo)radiotherapy or date of initial surgery
30 days
Phase III: For analyses incorporating the non-randomised standard surgery comparator - Non-regrowth Pelvic Tumour Control
Time Frame: 36 months
Non-regrowth pelvic tumour control to 36 months; defined as the length of time from the start date of (chemo)radiotherapy or date of initial surgery until death (any cause) or development of unequivocal pelvic recurrence but not including patients who preferred organ preservation and developed local regrowth which was resected with clear margins using standard TME surgery
36 months
Phase III: For analyses incorporating the non-randomised standard surgery comparator - Metastasis Free Survival
Time Frame: 36 months
Metastasis-free survival to 36 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause) or detection of distant metastasis
36 months
Phase III: For analyses incorporating the non-randomised standard surgery comparator - Disease-free Survival
Time Frame: 36 months
Disease-free survival to 36 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause), detection of local pelvic recurrence or distant metastasis but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery
36 months
Phase III: For analyses incorporating the non-randomised standard surgery comparator - Overall Survival
Time Frame: 60 months
Overall survival to 60 months defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause))
60 months
Phase III: For analyses incorporating the non-randomised standard surgery comparator - Decision Regret
Time Frame: 24 months
Decision regret at 24 months measured using the validated Decision regret scale questionnaire. The Decision Regret Scale is a 5-item Likert-type measure written to assess regret or remorse following a medical decision that takes less than 5 minutes to complete. High scores suggest high regret over a health care decision. Scores may be transformed to a scale of 0 (no regret) to 100 (high regret).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Bach, MD, University Hospitals Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG_15-011
  • 2016-000862-49 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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