RecruitingNot ApplicableNCT06328361

Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)


Sponsor

Tampere University Hospital

Enrollment

200 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (NOPPA) tests whether patients with rectal cancer who have a complete response to pre-surgery treatment (meaning the tumor appears to have disappeared on scans and examination) can safely avoid surgery altogether. This approach, called organ preservation or "watch and wait," spares patients from a major operation and potential stoma (colostomy bag) if the cancer has fully responded to radiation and/or chemotherapy. **You may be eligible if...** - You have rectal cancer confirmed by biopsy - After your pre-surgery treatment, your cancer showed a complete clinical response (no detectable tumor remaining) - You understand and consent to the organ preservation monitoring plan **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic disease) - You did not receive neoadjuvant therapy (pre-surgery treatment) - You cannot understand the risks and benefits of participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENonoperative surveillance

Clinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT


Locations(13)

East Tallinn Central Hospital

Tallinn, Estonia

North Estonia Medical Centre

Tallinn, Estonia

West Tallinn Central Hospital

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Helsinki University Central Hospital

Helsinki, Finland

Jyväskylä Central Hospital

Jyväskylä, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Satakunta Central Hospital

Pori, Finland

Seinajoki Central Hospital

Seinäjoki, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Vaasa Central Hospital

Vaasa, Finland

View Full Details on ClinicalTrials.gov

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NCT06328361


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