NCT06328361 Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
| NCT ID | NCT06328361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-05-16 |
| Primary Completion | 2028-12-31 |
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 200 participants in total. It began in 2024-05-16 with a primary completion date of 2028-12-31.
⚠ 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
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 Criteria
Inclusion Criteria: * Histopathological verification of primary rectal adenocarcinoma * Complete clinical response at response assessment after neoadjuvant therapy * Informed consent to organ preservation study Exclusion Criteria: * Evidence of metastatic disease (fulfilling M-class criteria of TNM) * No neoadjuvant therapy * Inability to understand the information related to harms and benefits
Contact & Investigator
Toni T Seppälä, MD, PhD
PRINCIPAL INVESTIGATOR
Tampere University Hospital
Frequently Asked Questions
Who can join the NCT06328361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying 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 NCT06328361 currently recruiting?
Yes, NCT06328361 is actively recruiting participants. Contact the research team at toni.seppala@tuni.fi for enrollment information.
Where is the NCT06328361 trial being conducted?
This trial is being conducted at Tallinn, Estonia, Tallinn, Estonia, Tallinn, Estonia, Tartu, Estonia and 9 additional locations.
Who is sponsoring the NCT06328361 clinical trial?
NCT06328361 is sponsored by Tampere University Hospital. The principal investigator is Toni T Seppälä, MD, PhD at Tampere University Hospital. The trial plans to enroll 200 participants.
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