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Taking people in EstoniaNo phase

Tests watchful waiting instead of surgery for rectal cancer after treatment

Studies watchful monitoring without surgery in adults with rectal cancer showing complete clinical response.

Plain-language title generated from the registry record
Registry title: Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Key facts

Where
Tallinn and Tartu, EstoniaSee the 4 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with rectal cancer (adenocarcinoma) whose tumour has fully gone after treatment before surgery. They would be watched instead of having an operation.

Age
18 years or older
Sex
All sexes can join
Disease stage
Primary rectal adenocarcinoma, confirmed by tissue examination, with a complete clinical response after treatment given before surgery (neoadjuvant therapy). No spread of the cancer to other organs.
Earlier treatment
Must have had neoadjuvant therapy (treatment given before surgery).

Main reasons for not taking part

  • Signs that the cancer has spread to other organs (metastatic disease)
  • No neoadjuvant therapy given
  • Cannot understand the information about harms and benefits

Read by machine on 9 November 2026.

Where in Estonia

  • East Tallinn Central HospitalTallinn, EstoniaTaking people
  • North Estonia Medical CentreTallinn, EstoniaTaking people
  • West Tallinn Central HospitalTallinn, EstoniaTaking people
  • Tartu University HospitalTartu, EstoniaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Tampere University Hospital
Trial code
NCT06328361
Record updated
30 September 2026
Original description
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 areRead full original descriptionShow less

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

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

Inclusion: Histopathological verification of primary rectal adenocarcinoma; Complete clinical response at response assessment after neoadjuvant therapy; Informed consent to organ preservation study.

Exclusion: No neoadjuvant therapy; Evidence of metastatic disease (fulfilling M-class criteria of TNM); Inability to understand the information related to harms and benefits.

ClinicalTrials.gov NCT06328361