Organ Preservation in Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER

Conditions
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LOCALLY ADVANCED RECTAL CANCER

Intervention / Treatment
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* Other: Organ Preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed histopathological diagnosis of rectal adenocarcinoma. Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy. Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI. Exclusion Criteria: Evidence of distant metastases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organ Preservation<br>The experimental strategy is the omission of radical surgery if complete or almost complete response after neoadjuvant treatment for locally advanced rectal cancer | Other: Organ Preservation<br>* Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy<br>* Other names: Watch and Wait;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local relapse rate | Occurrence of local relapse in patients with an organ preservation strategy | 2 years and 5 years | 
| Distant relapse rate | Occurrence of distant relapse in patients with an organ preservation strategy | 2 years and 5 years | 
| Quality of Life in oncological patients | Assess QLQ-C30 in patients with an organ preservation strategy | 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 | 3 months, 1 year and annually until 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORGAN PRESERVATION, WATCH AND WAIT, TRANSANAL ENDOSCOPIC MICROSURGERY