NCT03064646 Organ Preservation in Locally Advanced Rectal Cancer
| NCT ID | NCT03064646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana |
| Condition | LOCALLY ADVANCED RECTAL CANCER |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-03-10 |
| Primary Completion | 2022-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2017-03-10 with a primary completion date of 2022-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Javier Gallego, PhD
PRINCIPAL INVESTIGATOR
Hospital General Universitario de Elche
Frequently Asked Questions
Who can join the NCT03064646 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying LOCALLY ADVANCED RECTAL CANCER. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03064646 currently recruiting?
Yes, NCT03064646 is actively recruiting participants. Contact the research team at j.gallegoplazas@gmail.com for enrollment information.
Where is the NCT03064646 trial being conducted?
This trial is being conducted at Elche, Spain.
Who is sponsoring the NCT03064646 clinical trial?
NCT03064646 is sponsored by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana. The principal investigator is Javier Gallego, PhD at Hospital General Universitario de Elche. The trial plans to enroll 30 participants.
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