Abstract 277TiP
Background
The study hypothesis is that around 50% of rectal cancer patients can preserve their rectum by adopting a watch-and-wait strategy after achieving complete or near complete clinical response (cCR/ncCR) following total neoadjuvant therapy (TNT). Our objective is to determine whether the number of complications, quality of life, and survival of rectal cancer patients with a cCR/ncCR after TNT and rectal preservation with a watch-and-wait approach is not inferior to those of patients who underwent surgery as initial treatment. We are planning to identify potential prognostic/predictive markers.
Trial design
Design In this prospective, non-inferiority, randomized, controlled trial we will include patients with cT1N1, T2-T3 N0-1 rectal cancer, no involvement of mesorectal fascia (MRF), no extramural vascular invasion (EMVI). The experimental group will consist of patients undergoing TNT - chemoradiotherapy treatment with consolidation chemotherapy. If a cCR/ncCR is achieved, patients will be followed by watch-and-wait strategy - experimental non-operative approach. The control group will consist of patients undergoing surgical treatment first. Inclusion/exclusion criteria Inclusion criteria: patients over 18 years of age who agreed to participate in the study and signed an informed consent form. ECOG score between 0 and 2. Confirmed rectal adenocarcinoma. Tumor up to 10 cm from the anus. The diagnosis was confirmed by pelvic magnetic resonance imaging and chest and abdominal computed tomography. cT1N1, T2-T3 N0-2, M0 rectal cancer, MRF ±, EMVI ±. Exclusion criteria: previous radiotherapy or chemotherapy. Patients who cannot undergo pelvic magnetic imaging; a history of malignancy within the last 5 years, except treatment for basal cell or squamous cell skin cancer or cervical cancer in situ. ECOG status ≥ 3. Evidence of distant metastases. Patients with uncontrolled therapeutic or psychiatric conditions. Infectious diseases requiring antibiotic treatment.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.