PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment. The main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival. The secondary objective is to assess local relapse, distant relapse and quality of life.
After pathology confirmed rectal cancer patients with stage II and III (MRI, CT and endoscopy) will be identified in the first visit to Medical Oncology Department. Patients will receive the most appropriate neoadjuvant treatment according to clinical guidelines. Response to neoadjuvant treatment will be assessed by MRI. Those patients with a complete response in MRI, confirmed by endoscopy, will be offered a "watch and wait" strategy. Patients with a complete response in MRI, with an almost complete response in endoscopy, will be offered transanal endoscopic microsurgery. All patients with complete or near complete response will sign an informed consent before study entry. Radical surgery will be performed in patients without complete or almost complete response criteria after neoadjuvant treatment. Patients in organ preserving strategy will be subjected to a more intensive follow up schedule, including MRI and endoscopy, compared to patients with radical surgery. As the complete histopathologic response rate after neoadjuvant treatment in locally advanced rectal cancer is approximately 15-20%, considering that approximately 40 patients with locally advanced rectal cancer are diagnosed annually in our setting, approximately 6-8 patients per year could be potentially recruited for this project, until reaching an initial sample of 30 patients for evaluation. The following results will be analyzed: * Percentage of complete and almost complete responses. * Percentage of watch and wait and transanal endoscopic microsurgery. * Disease free survival. * Overall survival. * Local relapse rate. * Distant relapse rate. * Treatment and outcomes of relapses. * Colostomy free survival. * Quality of life. All data will be obtained from patient's medical records
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy
Hospital General Universitario de Elche
Elche, Alicante, Spain
RECRUITINGPercentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer
Patients with a complete or almost complete response after a neoadjuvant treatment will be offered an organ preservation strategy
Time frame: 5 years
Local relapse rate
Occurrence of local relapse in patients with an organ preservation strategy
Time frame: 2 years and 5 years
Distant relapse rate
Occurrence of distant relapse in patients with an organ preservation strategy
Time frame: 2 years and 5 years
Quality of Life in oncological patients
Assess QLQ-C30 in patients with an organ preservation strategy
Time frame: 3 months; 1 year and annually until 5 years
Quality of Life in patient with rectal cancer
Assess QLQ-CR38 in patients with an organ preservation strategy
Time frame: 3 months, 1 year and annually until 5 years
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