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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.

SUBMITTER: Borstlap WA

PROVIDER: S-EPMC4955121 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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

Borstlap W A A WA Tanis P J PJ Koedam T W A TW Marijnen C A M CA Cunningham C C Dekker E E van Leerdam M E ME Meijer G G van Grieken N N Nagtegaal I D ID Punt C J A CJ Dijkgraaf M G W MG De Wilt J H JH Beets G G de Graaf E J EJ van Geloven A A W AA Gerhards M F MF van Westreenen H L HL van de Ven A W H AW van Duijvendijk P P de Hingh I H J T IH Leijtens J W A JW Sietses C C Spillenaar-Bilgen E J EJ Vuylsteke R J C L M RJ Hoff C C Burger J W A JW van Grevenstein W M U WM Pronk A A Bosker R J I RJ Prins H H Smits A B AB Bruin S S Zimmerman D D DD Stassen L P S LP Dunker M S MS Westerterp M M Coene P P PP Stoot J J Bemelman W A WA Tuynman J B JB

BMC cancer 20160721

<h4>Background</h4>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 intermedi ...[more]

PMID: 27439975

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Project description:BACKGROUND:Neoadjuvant therapy can shrink tumors, increase anus preservation rate, and protect anal function. Radical surgery need cut off the diseased bowel, clean up the lymph nodes, and then restore bowel function. It could bring traumatic effect and poor postoperative quality of life to the patient. Local resection requires removal of the diseased bowel with circular negative margin. The surgical trauma is small, and the postoperative quality of life is good. In this meta-analysis, we aimed to evaluate the efficacy and safety between wait and see strategy (WS), radical surgery (RS), and local excision (LE) of rectal cancer patients with clinical complete response (cCR) response after neoadjuvant chemoradiotherapy. METHODS:We searched PubMed, Cochrane Library, CNKI (China National Knowledge Infrastructure), and Wanfang databases to compare wait and see strategy with radical surgery and local excision for rectal cancer with cCR response after neoadjuvant chemoradiotherapy up to March 2020. We collected the data of local recurrence, distant metastasis, cancer-related death, overall survival, and disease-free survival and used RevMan 5.0 to carry out the meta-analysis. Continuous data were evaluated by the standardized mean differences (SMD) with 95% confidence intervals (95% CIs), and dichotomous data were evaluated by relative risks (ORs or RRs) with 95% CIs. We aimed to compare the advantages and disadvantages of the three groups. RESULTS:Eleven English studies with 1131 patients were included. There were 412 patients in WS group, 678 patients in RS group, and 41 patients in LE group. WS group had a higher local recurrence rate than RS group (OR 7.32, 95% CI 3.58 to 14.95, P < 0.001). There was no significant difference in the other data between the three groups. CONCLUSION:Compared with the RS group, the WS group had an increased risk of local recurrence. However, the WS group had a similar DFS and OS compared with the RS group and the local excision group. Hence, we speculated that the WS group would have similar results as the surgery group for patients with cCR status.

Dataset Information

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

Publications

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

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