Servicio de Salud Metropolitano Sur Oriente is recruiting patients with locally advanced rectal cancer

This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherapy (5x5Gy) followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained (>1year) complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy (CRT), total mesorectal excision (TME) and adjuvant chemotherapy (ACT).

Non-operative management with a Watch and Wait (W&W) strategy has been advocated for selected patients with a locally advanced rectal cancer (LARC) and a complete clinical response (cCR) after neoajuvant (NA) treatment. In this context, total neoadjuvant therapy (TNT), i.e the use of radiotherapy and full dose of post-operative chemotherapy as part of NA treatment, has emerged as a strategy to enhance treatment response. Currently, TNT has reported higher rates of pCR and organ preservation when compared to current standard of care. However, the best TNT strategy is still unknown.

The researchers plan that May 1, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in October 30, 2023.

Among primary outcome measures are the Rate of pathological and sustained clinical response and Combined number of patients with pathological response in the surgical specimen and patients in a Watch and Wait protocol with a sustained clinical response longer than a year.

The study will take place at the Complejo Asistencial Doctor Sótero del Rio, Santiago, RM, Chile; Hospital La Florida, Santiago, RM, Chile; Hospital Padre Hurtado, Santiago, RM, Chile.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04864067.

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