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

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.DiscussionThe 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

Transanal endoscopic microsurgery for rectal lesions in a specialist regional early rectal cancer centre: the Mersey experience

“…Although these numbers are small and the follow‐up period relatively short, our findings are in line with previous studies which support the role of adjuvant therapy following TEMS . However, the existing literature is limited to small series with wide variation of recurrence rates (6–43%) . The ongoing TESAR trial will assess oncological outcome in patients receiving adjuvant therapy after TEMS compared with patients undergoing radical surgery.…”

Transanal Endoscopic Microsurgery with or without Completion Total Mesorectal Excision for T2 and T3 Rectal Carcinoma

“…If an unexpected T2–3 rectal carcinoma after local excision is discovered, rectal saving therapy might be suggested with postoperative (chemo)radiotherapy, as it could decrease the local recurrence [24]. This is, however, not common practice at the moment in the Netherlands, as clear evidence is lacking and data of the randomized clinical trial TESAR comparing adjuvant chemoradiotherapy after local excision versus completion TME are yet to be collected [25]. Therefore, we believe that this study, despite these limitations, provides evidence that for a specific group of patients, TEM for pT2 and pT3 might be a valid alternative for completion TME when all options are to be discussed with the patient.…”

Comparison of guidelines for the management of rectal cancer

“…Regarding postoperative chemo/radiotherapy, NCCN supported this indication for T1–2 tumours after transanal excision, mainly as an alternative to radical surgery. In the same way, only NCCN guidelines advised adjuvant treatment for stage II cancer.…”