About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Evidence of distant metastases.
Trial design
Treatments tested in this trial
- Organ Preservation
Treatment groups
Sponsors and collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Lead sponsor
Hospital General Universitario Elche
Collaborator