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; C. J. A. Punt; M. G. W. Dijkgraaf; J. H. De Wilt; Geerard Beets; E. J. de Graaf; A. A. W. van Geloven; M. F. Gerhards; H. L. van Westreenen; A. W. H. van de Ven; P. van Duijvendijk; I. H. J. T. de Hingh; J. W. A. Leijtens; C. Sietses; E. J. Spillenaar-Bilgen; R. J. C. L. M. Vuylsteke; C. Hoff; J. W. A. Burger; W. M. U. van Grevenstein; A. Pronk; R. J. I. Bosker; H. Prins; A. B. Smits; S. Bruin; D. D. Zimmerman; L. P. S. Stassen; M. S. Dunker; M. Westerterp; P. P. Coene; J. Stoot; W. A. Bemelman; J. B. Tuynman

doi:10.1186/s12885-016-2557-x

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, C. J. A. Punt, M. G. W. Dijkgraaf, J. H. De Wilt, Geerard Beets, E. J. de Graaf, A. A. W. van Geloven, M. F. Gerhards, H. L. van Westreenen, A. W. H. van de Ven, P. van DuijvendijkI. H. J. T. de Hingh, J. W. A. Leijtens, C. Sietses, E. J. Spillenaar-Bilgen, R. J. C. L. M. Vuylsteke, C. Hoff, J. W. A. Burger, W. M. U. van Grevenstein, A. Pronk, R. J. I. Bosker, H. Prins, A. B. Smits, S. Bruin, D. D. Zimmerman, L. P. S. Stassen, M. S. Dunker, M. Westerterp, P. P. Coene, J. Stoot, W. A. Bemelman, J. B. Tuynman^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background: 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. Methods/Study design: 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. 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.

Original language	English
Article number	513
Number of pages	8
Journal	BMC Cancer
Volume	16
DOIs	https://doi.org/10.1186/s12885-016-2557-x
Publication status	Published - 21 Jul 2016

Keywords

Rectal cancer
Organ preserving
TEM
Adjuvant chemoradiotherapy

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10.1186/s12885-016-2557-xLicence: CC BY

Cite this

Borstlap, W. A. A., Tanis, P. J., Koedam, T. W. A., Marijnen, C. A. M., Cunningham, C., Dekker, E., van Leerdam, M. E., Meijer, G., van Grieken, N., Nagtegaal, I. D., Punt, C. J. A., Dijkgraaf, M. G. W., De Wilt, J. H., Beets, G., de Graaf, E. J., van Geloven, A. A. W., Gerhards, M. F., van Westreenen, H. L., van de Ven, A. W. H., ... Tuynman, J. B. (2016). A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer. BMC Cancer, 16, Article 513. https://doi.org/10.1186/s12885-016-2557-x

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title = "A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer",

abstract = "Background: 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. Methods/Study design: 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. 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.",

keywords = "Rectal cancer, Organ preserving, TEM, Adjuvant chemoradiotherapy",

author = "Borstlap, {W. A. A.} and Tanis, {P. J.} and Koedam, {T. W. A.} and Marijnen, {C. A. M.} and C. Cunningham and E. Dekker and {van Leerdam}, {M. E.} and G. Meijer and {van Grieken}, N. and Nagtegaal, {I. D.} and Punt, {C. J. A.} and Dijkgraaf, {M. G. W.} and {De Wilt}, {J. H.} and Geerard Beets and {de Graaf}, {E. J.} and {van Geloven}, {A. A. W.} and Gerhards, {M. F.} and {van Westreenen}, {H. L.} and {van de Ven}, {A. W. H.} and {van Duijvendijk}, P. and {de Hingh}, {I. H. J. T.} and Leijtens, {J. W. A.} and C. Sietses and Spillenaar-Bilgen, {E. J.} and Vuylsteke, {R. J. C. L. M.} and C. Hoff and Burger, {J. W. A.} and {van Grevenstein}, {W. M. U.} and A. Pronk and Bosker, {R. J. I.} and H. Prins and Smits, {A. B.} and S. Bruin and Zimmerman, {D. D.} and Stassen, {L. P. S.} and Dunker, {M. S.} and M. Westerterp and Coene, {P. P.} and J. Stoot and Bemelman, {W. A.} and Tuynman, {J. B.}",

year = "2016",

month = jul,

day = "21",

doi = "10.1186/s12885-016-2557-x",

language = "English",

volume = "16",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central Ltd",

}

Borstlap, WAA, Tanis, PJ, Koedam, TWA, Marijnen, CAM, Cunningham, C, Dekker, E, van Leerdam, ME, Meijer, G, van Grieken, N, Nagtegaal, ID, Punt, CJA, Dijkgraaf, MGW, De Wilt, JH, Beets, G, de Graaf, EJ, van Geloven, AAW, Gerhards, MF, van Westreenen, HL, van de Ven, AWH, van Duijvendijk, P, de Hingh, IHJT, Leijtens, JWA, Sietses, C, Spillenaar-Bilgen, EJ, Vuylsteke, RJCLM, Hoff, C, Burger, JWA, van Grevenstein, WMU, Pronk, A, Bosker, RJI, Prins, H, Smits, AB, Bruin, S, Zimmerman, DD, Stassen, LPS, Dunker, MS, Westerterp, M, Coene, PP, Stoot, J, Bemelman, WA & Tuynman, JB 2016, 'A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer', BMC Cancer, vol. 16, 513. https://doi.org/10.1186/s12885-016-2557-x

TY - JOUR

T1 - A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer

AU - Borstlap, W. A. A.

AU - Tanis, P. J.

AU - Koedam, T. W. A.

AU - Marijnen, C. A. M.

AU - Cunningham, C.

AU - Dekker, E.

AU - van Leerdam, M. E.

AU - Meijer, G.

AU - van Grieken, N.

AU - Nagtegaal, I. D.

AU - Punt, C. J. A.

AU - Dijkgraaf, M. G. W.

AU - De Wilt, J. H.

AU - Beets, Geerard

AU - de Graaf, E. J.

AU - van Geloven, A. A. W.

AU - Gerhards, M. F.

AU - van Westreenen, H. L.

AU - van de Ven, A. W. H.

AU - van Duijvendijk, P.

AU - de Hingh, I. H. J. T.

AU - Leijtens, J. W. A.

AU - Sietses, C.

AU - Spillenaar-Bilgen, E. J.

AU - Vuylsteke, R. J. C. L. M.

AU - Hoff, C.

AU - Burger, J. W. A.

AU - van Grevenstein, W. M. U.

AU - Pronk, A.

AU - Bosker, R. J. I.

AU - Prins, H.

AU - Smits, A. B.

AU - Bruin, S.

AU - Zimmerman, D. D.

AU - Stassen, L. P. S.

AU - Dunker, M. S.

AU - Westerterp, M.

AU - Coene, P. P.

AU - Stoot, J.

AU - Bemelman, W. A.

AU - Tuynman, J. B.

PY - 2016/7/21

Y1 - 2016/7/21

N2 - Background: 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. Methods/Study design: 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. 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.

AB - Background: 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. Methods/Study design: 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. 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.

KW - Rectal cancer

KW - Organ preserving

KW - TEM

KW - Adjuvant chemoradiotherapy

U2 - 10.1186/s12885-016-2557-x

DO - 10.1186/s12885-016-2557-x

M3 - Article

C2 - 27439975

SN - 1471-2407

VL - 16

JO - BMC Cancer

JF - BMC Cancer

M1 - 513

ER -