title: A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.
abstract: Rectal 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.
  
  
  
  In 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.
  
  
  
  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.
  
  
  
  NCT02371304 , registration date: February 2015.
authors.affiliation: Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: W A A
authors.initials: WA
authors.lastname: Borstlap
authors.affiliation: Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: Tanis
authors.affiliation: Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.
authors.forename: T W A
authors.initials: TW
authors.lastname: Koedam
authors.affiliation: Department of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: C A M
authors.initials: CA
authors.lastname: Marijnen
authors.affiliation: Department of Surgery, Oxford University Hospital, Oxford, UK.
authors.forename: C
authors.initials: C
authors.lastname: Cunningham
authors.affiliation: Department of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Dekker
authors.affiliation: Department of Gastroenterology, Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.
authors.forename: M E
authors.initials: ME
authors.lastname: van Leerdam
authors.affiliation: Department of Pathology, Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Meijer
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: N
authors.initials: N
authors.lastname: van Grieken
authors.affiliation: Department of Pathology, RadboudUMC, Nijmegen, The Netherlands.
authors.forename: I D
authors.initials: ID
authors.lastname: Nagtegaal
authors.affiliation: Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: C J A
authors.initials: CJ
authors.lastname: Punt
authors.affiliation: Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.affiliation: Department of Surgery, RadboudUMC, Nijmegen, The Netherlands.
authors.forename: J H
authors.initials: JH
authors.lastname: De Wilt
authors.affiliation: Department of Surgery, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Beets
authors.affiliation: Department of Surgery, IJselland Hospital, Capelle aan de Ijssel, The Netherlands.
authors.forename: E J
authors.initials: EJ
authors.lastname: de Graaf
authors.affiliation: Department of surgery, Tergooi Hospital, Hilversum, The Netherlands.
authors.forename: A A W
authors.initials: AA
authors.lastname: van Geloven
authors.affiliation: Department of surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: M F
authors.initials: MF
authors.lastname: Gerhards
authors.affiliation: Department of surgery, Isala Hospital, Zwolle, The Netherlands.
authors.forename: H L
authors.initials: HL
authors.lastname: van Westreenen
authors.affiliation: Department of surgery, Flevo Hospital, Almere, The Netherlands.
authors.forename: A W H
authors.initials: AW
authors.lastname: van de Ven
authors.affiliation: Department of surgery, Gelre Hospital, Apeldoorn, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: van Duijvendijk
authors.affiliation: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors.forename: I H J T
authors.initials: IH
authors.lastname: de Hingh
authors.affiliation: Department of Surgery, Laurentius Hospital, Roermond, The Netherlands.
authors.forename: J W A
authors.initials: JW
authors.lastname: Leijtens
authors.affiliation: Department of Surgery, Gelderse Vallei Hospital, Ede, The Netherlands.
authors.forename: C
authors.initials: C
authors.lastname: Sietses
authors.affiliation: Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
authors.forename: E J
authors.initials: EJ
authors.lastname: Spillenaar-Bilgen
authors.affiliation: Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.
authors.forename: R J C L M
authors.initials: RJ
authors.lastname: Vuylsteke
authors.affiliation: Department of Surgery, Medisch Centrum Leewarden, Leeuwarden, The Netherlands.
authors.forename: C
authors.initials: C
authors.lastname: Hoff
authors.affiliation: Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: J W A
authors.initials: JW
authors.lastname: Burger
authors.affiliation: Department of Surgery, University Medical Center, Utrecht, The Netherlands.
authors.forename: W M U
authors.initials: WM
authors.lastname: van Grevenstein
authors.affiliation: Department of Surgery, Diaconessenziekehuis, Utrecht, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Pronk
authors.affiliation: Department of Surgery, Deventer Hospital, Deventer, The Netherlands.
authors.forename: R J I
authors.initials: RJ
authors.lastname: Bosker
authors.affiliation: Department of Surgery, Jeroen Bosch Hospital, Den Bosch, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Prins
authors.affiliation: Department of Surgery, Sint. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: A B
authors.initials: AB
authors.lastname: Smits
authors.affiliation: Department of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Bruin
authors.affiliation: Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
authors.forename: D D
authors.initials: DD
authors.lastname: Zimmerman
authors.affiliation: Department of Surgery, MUMC, Maastricht, The Netherlands.
authors.forename: L P S
authors.initials: LP
authors.lastname: Stassen
authors.affiliation: Department of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.
authors.forename: M S
authors.initials: MS
authors.lastname: Dunker
authors.affiliation: Department of Surgery, Medical Center Haaglanden, The Hague, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Westerterp
authors.affiliation: Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands.
authors.forename: P P
authors.initials: PP
authors.lastname: Coene
authors.affiliation: Department of Surgery, Zuyderland Hospital, Sittard, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Stoot
authors.affiliation: Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: W A
authors.initials: WA
authors.lastname: Bemelman
authors.affiliation: Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands. j.tuynman@vumc.nl.
authors.forename: J B
authors.initials: JB
authors.lastname: Tuynman
mesh_terms: D059186:Chemoradiotherapy, Adjuvant; D003082:Colectomy; D006801:Humans; D012004:Rectal Neoplasms / Q000628:therapy*; D012107:Research Design
keywords: Adjuvant chemoradiotherapy; Organ preserving; Rectal cancer; TEM