TESAR: Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.
Trial Overview
| Acronym | TESAR |
|---|---|
| Number | NCT02371304 |
| Protocol Link | https://bmccancer.biomedcentral.com/articles/10.1186/s12885-016-2557-x |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT02371304?term=TESAR&rank=1 |
| Status | Open/recruiting |
| Category | Colorectal Cancer - Rectal Specific |
| Treatment Course | Adjuvant, palliative or post-op |
Trial Description
| The TESAR trial is a multicentred randomised trial in which patiens with intermediate risk early rectal cancer after local endoluminal excision will be randomised between an additional TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3 three year follow-up. |
Chief Investigator
|
J.B. Tuynman MD, PhD |
| Profile Link |
Lead Centre
|
Amsterdam UMC, location VUmc De Boelelaan 1117 Amsterdam 1081HV The Netherlands |
| Website |
Collaboration and Funding
Funding Sponsors
| 1. Dutch Cancer Society The Dutch Cancer Society (DCS) is a nation-wide organization for cancer related work in the Netherlands. |
Additional Information
Full Research Summary| Objective: | 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. |
| Aim: | To evaluate a rectal preserving treatment strategy outcomes in patients with intermediate risk early rectal cancer. A non-inferiority design study between adjuvant mesorectal chemoradiation and completion TME after local excision. |
| Methods: | 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. |
| Reason for International Trial: | Rectal preserving therapy is increasingly supported by surgeons and gastroenterologists in different countries. The trial was initialy set up in The Netherlands, but will expand to French hospitals. |