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

Summary

Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME). Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated with substantial loss of health related quality of life due to defecation disorders, incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are acceptable when radical surgery is the only option for cure. Advances in technology enabled the development of local excision of early rectal cancer with precise endoluminal microsurgery or local endoscopic excision resulting in a significant decrease in short- and long term morbidity. However current evidence is of inadequate quality to conclude on the oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment of the excised tumor tissue provides the optimal information on tumor stage, tumor characteristics and tumor differentiation, thereby it enables to predict the risk of recurrence after local treatment alone. For early rectal cancers, with a low risk on recurrence based on favourable tumor characteristics local excision is seen as safe and these patients do not require an additional treatment. However, for patients with early rectal cancer with a higher risk on recurrence based on tumor characteristics there is no consensus on the additional treatment after local excision. According to the National guideline these patients receive a TME procedure. However, for this subgroup of patients local treatment followed by chemoradiotherapy might also be oncological safe. Current evidence is of inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be randomised after local endoluminal excision between an additional TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3 three year follow-up.

Timeline

Start

2015-10

Primary completion

2022-06

Completion

2023-01

Outcome

Missed primary endpoint

paper Adjuvant chemoradiotherapy did not meet the non-inferiority margin of 7% for 3-year locoregional recurrence PMID 42202843 ↗

Publications

• Moolenaar LR, Ali M, Aufenacker TJ, Beets GL, Bosker RJI, Buffart TE, Burger JW, Dekker E, Denost Q, Doornebosch PG, Duijvendijk PV, Fabry HFJ, Geijsen ED, Gerhards MF, van Grevenstein WMU, Grotenhuis BA, Hoff C, Leijtens JWA, Peeters KCMJ, Pronk A, van der Schelling GP, Sietses C, Smits AB, Toorenvliet BR, van de Ven AWH, Verdaasdonk EGG, Vuylsteke RJCLM, van Westreenen HL, de Wilt JHW, Zimmerman DDE, Lange MM, van Grieken NCT, Bastiaansen BAJ, Hompes R, Marijnen CA, Dijkgraaf MGW, Moons LMG, Tanis PJ, Cunningham C, Tuynman JB; TESAR Study Group. Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 Jul;11(7):557-569. doi: 10.1016/S2468-1253(26)00109-3. Epub 2026 May 27.
• Borstlap WA, Tanis PJ, Koedam TW, Marijnen CA, Cunningham C, Dekker E, van Leerdam ME, Meijer G, van Grieken N, Nagtegaal ID, Punt CJ, Dijkgraaf MG, De Wilt JH, Beets G, de Graaf EJ, van Geloven AA, Gerhards MF, van Westreenen HL, van de Ven AW, van Duijvendijk P, de Hingh IH, Leijtens JW, Sietses C, Spillenaar-Bilgen EJ, Vuylsteke RJ, Hoff C, Burger JW, van Grevenstein WM, Pronk A, Bosker RJ, Prins H, Smits AB, Bruin S, Zimmerman DD, Stassen LP, Dunker MS, Westerterp M, Coene PP, Stoot J, Bemelman WA, Tuynman JB. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer. BMC Cancer. 2016 Jul 21;16:513. doi: 10.1186/s12885-016-2557-x.

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Indications