Evidence map›Paper›PMID 27439975›Full record

Trial reportBMC cancer2016

A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.

W A A Borstlap, P J Tanis, T W A Koedam, C A M Marijnen, C Cunningham, E Dekker, M E van Leerdam, G Meijer, N van Grieken, I D Nagtegaal and 31 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02371304 (Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers), which is not on this map. Cited by 48 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 5 pooled it
3.5field-weighted citation impact, top 6% 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.

NCT02371304 phase3unknown statusnot on this map

Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2015 to 2023Enrolled302ConditionsRectal CancerArmsAdjuvant chemoradiotherapy, Additional TME surgery, capecitabine
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Indocyanine green-guided robotic-assisted mesorectal lymphadenectomy for high-risk T1 rectal carcinoma: Preliminary results of a prospective cohort study (IDEAL stage 2a).Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026
    Observational
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Endoscopic resectionTranslational cancer research · 2024
    Article
  19. Article
  20. Article
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

41 authors at 20 institutions in 2 countries.

W A A BorstlapDepartment of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
P J TanisDepartment of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
T W A KoedamDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.
C A M MarijnenDepartment of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
C CunninghamDepartment of Surgery, Oxford University Hospital, Oxford, UK.
E DekkerDepartment of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
M E van LeerdamDepartment of Gastroenterology, Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.
G MeijerDepartment of Pathology, Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.
N van GriekenDepartment of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
I D NagtegaalDepartment of Pathology, RadboudUMC, Nijmegen, The Netherlands.
C J A PuntDepartment of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
M G W DijkgraafClinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
J H De WiltDepartment of Surgery, RadboudUMC, Nijmegen, The Netherlands.
G BeetsDepartment of Surgery, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
E J de GraafDepartment of Surgery, IJselland Hospital, Capelle aan de Ijssel, The Netherlands.
A A W van GelovenDepartment of surgery, Tergooi Hospital, Hilversum, The Netherlands.
M F GerhardsDepartment of surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
H L van WestreenenDepartment of surgery, Isala Hospital, Zwolle, The Netherlands.
A W H van de VenDepartment of surgery, Flevo Hospital, Almere, The Netherlands.
P van DuijvendijkDepartment of surgery, Gelre Hospital, Apeldoorn, The Netherlands.
I H J T de HinghDepartment of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
J W A LeijtensDepartment of Surgery, Laurentius Hospital, Roermond, The Netherlands.
C SietsesDepartment of Surgery, Gelderse Vallei Hospital, Ede, The Netherlands.
E J Spillenaar-BilgenDepartment of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
R J C L M VuylstekeDepartment of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.
C HoffDepartment of Surgery, Medisch Centrum Leewarden, Leeuwarden, The Netherlands.
J W A BurgerDepartment of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
W M U van GrevensteinDepartment of Surgery, University Medical Center, Utrecht, The Netherlands.
A PronkDepartment of Surgery, Diaconessenziekehuis, Utrecht, The Netherlands.
R J I BoskerDepartment of Surgery, Deventer Hospital, Deventer, The Netherlands.
H PrinsDepartment of Surgery, Jeroen Bosch Hospital, Den Bosch, The Netherlands.
A B SmitsDepartment of Surgery, Sint. Antonius Hospital, Nieuwegein, The Netherlands.
S BruinDepartment of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands.
D D ZimmermanDepartment of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
L P S StassenDepartment of Surgery, MUMC, Maastricht, The Netherlands.
M S DunkerDepartment of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.
M WesterterpDepartment of Surgery, Medical Center Haaglanden, The Hague, The Netherlands.
P P CoeneDepartment of Surgery, Maasstad Hospital, Rotterdam, The Netherlands.
J StootDepartment of Surgery, Zuyderland Hospital, Sittard, The Netherlands.
W A BemelmanDepartment of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
J B TuynmanDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands. j.tuynman@vumc.nl.
University of Amsterdam · NLAmsterdam UMC Location VUmc · NLRadboud University Nijmegen · NLThe Netherlands Cancer Institute · NLAcademic Medical Center · NLDe Kinderkliniek · NLDeventer Ziekenhuis · NLDiakonessenhuis hospital · NLElisabeth-TweeSteden Ziekenhuis · NLErasmus MC · NLGelre Hospitals · NLIJsselland Ziekenhuis · NLIsala · NLJeroen Bosch Ziekenhuis · NLLaurentius Ziekenhuis · NLLeiden University Medical Center · NLMaasstad Ziekenhuis · NLMaastricht University Medical Centre · NLMedisch Centrum Haaglanden · NLMedisch Centrum Leeuwarden · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. METHODS/STUDY

designIn this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. DISCUSSION: The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion TME surgery.

trial registrationNCT02371304 , registration date: February 2015.

Indexed as

Chemoradiotherapy, AdjuvantColectomyResearch DesignHumansRectal NeoplasmsAdjuvant chemoradiotherapyOrgan preservingRectal cancerTEM

Identifiers

PMID27439975
PMCPMC4955121
OpenAlexW2485439683

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.