Last updated 10 months ago

No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer

73 patients around the world
Available in Chile
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. We therefore hypothesize that in LARC patients, the use of a TNT strategy based on short course RT followed by consolidation chemotherapy is associated with a higher rate of pCR and sustained (>1year) cCR when compared to an historic cohort. The main aim of the present proposal is to assess the effects of a standardized TNT model in LARC patients as a strategy for enhanced pCR/sustained cCR. For this purpose, we propose the following experimental model: In primary Aim 1 we will study if the effects of a TNT strategy over patients with a LARC enhance the rate of pCR/sustained cCR by (1) evaluating the compliance and toxicity of a TNT strategy as a proof of concept of its applicability, (2) assessing the rate of cCR at the end of TNT and (3) assessing the rate of pCR in the surgically managed subgroup and sustained cCR (>1year) in the W&W subgroup. Additionally, in primary Aim 2, we will determine if patients with a W&W strategy have better functional outcomes and quality of life (QoL) than patients treated with TME after TNT by (1) using validated questionnaires for the evaluation of bowel, sexual and urinary function for W&W and TME patients and (2) by evaluating the QoL using a widely-used standardized questionnaire.
Servicio de Salud Metropolitano Sur Oriente
3Research sites
73Patients around the world
This study is for people with
Colorectal cancer
Rectal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
Hospital La Florida Dra. Eloísa Díaz
Recruiting
Froilán Roa 6542, La Florida, Región Metropolitana
Hospital Padre Hurtado
Recruiting
Esperanza 2150, San Ramón, Región Metropolitana, Santiago
Hospital Dr. Sótero del Río
Recruiting
Av. Concha Y Toro 3459, Puente Alto, Región Metropolitana, Santiago
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