ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital General Universitario de Elche
RECRUITING
Elche
Contact Information
Primary
Javier Gallego, PhD
j.gallegoplazas@gmail.com
+34966616250
Time Frame
Start Date: 2017-03-10
Estimated Completion Date: 2027-02
Participants
Target number of participants: 30
Treatments
Experimental: Organ Preservation
The experimental strategy is the omission of radical surgery if complete or almost complete response after neoadjuvant treatment for locally advanced rectal cancer
Related Therapeutic Areas
Sponsors
Leads: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Collaborators: Hospital General Universitario Elche

This content was sourced from clinicaltrials.gov