Organ Preservation in Locally Advanced Rectal Cancer
ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
30 participants
Mar 10, 2017
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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 Criteria1
- Evidence of distant metastases.
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Interventions
Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03064646