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Organ Preservation in Locally Advanced Rectal Cancer

RECRUITINGN/ASponsored by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Actively Recruiting
PhaseN/A
SponsorFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Started2017-03-10
Est. completion2022-02
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT03064646

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerLocally Advanced Rectal Cancer

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