Actively Recruiting
Organ Preservation in Locally Advanced Rectal Cancer
Led by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Updated on 2018-09-27
30
Participants Needed
1
Research Sites
516 weeks
Total Duration
On this page
Sponsors
F
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Lead Sponsor
H
Hospital General Universitario Elche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Organ Preservation in Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Evidence of distant metastases.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
Research Team
J
Javier Gallego, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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