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.
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.
Evidence of distant metastases.
Single group
Organ Preservation
Other interventionPatients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy
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
Local relapse rate
Occurrence of local relapse in patients with an organ preservation strategy
Distant relapse rate
Occurrence of distant relapse in patients with an organ preservation strategy
Quality of Life in oncological patients
Assess QLQ-C30 in patients with an organ preservation strategy
Quality of Life in patient with rectal cancer
Assess QLQ-CR38 in patients with an organ preservation strategy
Percentage of complete and almost complete responses
Occurrence of complete and almost complete responses assessed by MRI and confirmed by endoscopy after neoadjuvant treatment
Disease free survival
Time without recidive
Overall Survival
Survival time from surgery
Treatment of relapses
Treatment administered in case of relapse
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Lead sponsor
Hospital General Universitario Elche
Collaborator
