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Clinical Trials in Spain / NCT03064646
Recruiting Not applicable

Organ Preservation in Locally Advanced Rectal Cancer

NCT03064646 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Phase
Not applicable
Started
2017-03-10
Last updated
2018-09-27

Condition(s) studied

LOCALLY ADVANCED RECTAL CANCER

Investigational drug(s) / intervention(s)

Organ Preservation

Organ Preservation: Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Evidence of distant metastases.

Primary outcome measure(s)

  • Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer — 5 years
    Patients with a complete or almost complete response after a neoadjuvant treatment will be offered an organ preservation strategy

Trial sites (1)

FacilityCityRegionStatus
Hospital General Universitario de Elche Elche Alicante Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03064646 on ClinicalTrials.gov ↗ ← All trials in Spain