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

RECRUITINGN/ASponsored by Tampere University Hospital
Actively Recruiting
PhaseN/A
SponsorTampere University Hospital
Started2024-05-16
Est. completion2028-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06328361

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerRectal AdenocarcinomaRectal Cancer

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