Organ preservation approach for locally advanced rectal cancer
ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER
This study is testing if a new approach to treating locally advanced rectal cancer can safely help patients keep their organs while monitoring their recovery after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Elche, Alicante) |
| Trial ID | NCT03064646 on ClinicalTrials.gov |
What this trial studies
The PRONAR trial evaluates the feasibility and safety of an organ preservation strategy for patients with locally advanced rectal cancer who show a complete or nearly complete response to neoadjuvant treatment. Patients will undergo MRI and endoscopy to assess their response, with those meeting criteria offered a 'watch and wait' strategy or transanal endoscopic microsurgery. The study aims to analyze survival rates, local and distant relapse, and quality of life outcomes. A total of 30 patients will be recruited over a period of time to assess these outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with stage II and III rectal adenocarcinoma who have shown a complete or near complete response to neoadjuvant treatment.
Not a fit: Patients with evidence of distant metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for radical surgery in patients with locally advanced rectal cancer, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with organ preservation strategies in rectal cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Elche, Alicante
- Hospital General Universitario de Elche — Elche, Alicante, Spain (Recruiting)
Study contacts
- Principal investigator: Javier Gallego, PhD — Hospital General Universitario de Elche
- Study coordinator: Javier Gallego, PhD
- Email: j.gallegoplazas@gmail.com
- Phone: +34966616250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.