Evidence map›Paper›PMID 35114057›Full record

ArticleColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland2022

Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC)? Protocol for the international, multicentre, rolling phase II/III partially randomized patient preference trial evaluating long-course concurrent chemoradiotherapy versus short-course radiotherapy organ preservation approaches.

Simon P Bach, STAR-TREC Collaborative

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 74 citations in OpenAlex.

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  16. Neoadjuvant Treatment in Rectal Cancer.South Asian journal of cancer · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 2 countries.

Simon P BachD3B [Drugs, Devices, Diagnostics and Biomarkers], Cancer Research UK Clinical Trials Unit, Birmingham, UK.ORCID 0000-0001-8412-7241
STAR-TREC Collaborative
Apple (Israel) · ILCancer Research UK Clinical Trials Unit · GB

Funding

Cancer Research UK 25354Cancer Research UK 28538Cancer Research UK CRUK/19/005
6 · The paper itself

Abstract

aimOrgan-saving treatment for early-stage rectal cancer can reduce patient-reported side effects compared to standard total mesorectal excision (TME) and preserve quality of life. An optimal strategy for achieving organ preservation and longer-term oncological outcomes are unknown; thus there is a need for high quality trials.

methodCan we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC) is an international three-arm multicentre, partially randomized controlled trial incorporating an external pilot. In phase III, patients with cT1-3b N0 tumours, ≤40 mm in diameter, who prefer organ preservation are randomized 1:1 between mesorectal long-course chemoradiation versus mesorectal short-course radiotherapy, with selective transanal microsurgery. Patients preferring radical surgery receive TME. STAR-TREC aims to recruit 380 patients to organ preservation and 120 to TME surgery. The primary outcome is the rate of organ preservation at 30 months. Secondary clinician-reported outcomes include acute treatment-related toxicity, rate of non-operative management, non-regrowth pelvic tumour control at 36 months, non-regrowth disease-free survival at 36 months and overall survival at 60 months, and patient-reported toxicity, health-related quality of life at baseline, 12 and 24 months. Exploratory biomarker research uses circulating tumour DNA to predict response and relapse. DISCUSSION: STAR-TREC will prospectively evaluate contrasting therapeutic strategies and implement new measures including a smaller mesorectal target volume, two-step response assessment and non-operative management for complete response. The trial will yield important information to guide routine management of patients with early-stage rectal cancer.

Indexed as

Rectal NeoplasmsRectumChemoradiotherapyClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicNeoplasm Recurrence, LocalOrgan PreservationPatient PreferenceQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeWatchful Waitingchemoradiotherapycirculating free tumour DNAcomplete responseearly rectal cancerorgan preservationshort-course radiotherapytransanal endoscopic microsurgerywatch and wait

Identifiers

PMID35114057
PMCPMC9311773
OpenAlexW4210326474

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.