NCT06328361

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
81mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
May 2024Dec 2032

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

4.6 years

First QC Date

March 18, 2024

Last Update Submit

August 25, 2025

Conditions

Rectal CancerRectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Survival from complete clinical response to locoregional failure or distant metastases

    2 years

Secondary Outcomes (12)

  • Overall survival

    5 years

  • TME-free survival

    5 years

  • ctDNA-free survival

    5 years

  • Post local regrowth disease-free survival

    5 years

  • Post local regrowth overall survival

    5 years

  • +7 more secondary outcomes

Study Arms (1)

Nonoperative management

EXPERIMENTAL

The patients presenting with complete clinical response undergo nonoperative management (i.e. watch \& wait) as surveillance for local regrowth or distant spread.

Procedure: Nonoperative surveillance

Interventions

Nonoperative surveillancePROCEDURE

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

Also known as: Watch and Wait, Organ preservation
Nonoperative management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

East Tallinn Central Hospital

Tallinn, Estonia

RECRUITING

North Estonia Medical Centre

Tallinn, Estonia

RECRUITING

West Tallinn Central Hospital

Tallinn, Estonia

RECRUITING

Tartu University Hospital

Tartu, Estonia

RECRUITING

Helsinki University Central Hospital

Helsinki, 00290, Finland

RECRUITING

Jyväskylä Central Hospital

Jyväskylä, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Satakunta Central Hospital

Pori, Finland

RECRUITING

Seinajoki Central Hospital

Seinäjoki, Finland

RECRUITING

Tampere University Hospital

Tampere, 33400, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Vaasa Central Hospital

Vaasa, 65100, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Organ Preservation

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Tissue PreservationPreservation, BiologicalTherapeuticsInvestigative Techniques

Study Officials

  • Toni T Seppälä, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Toni T Seppälä, MD, PhD

CONTACT

+358444722846toni.seppala@tuni.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

May 16, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2032

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The European Data Protection Regulation (GDPR) does not allow sharing other than anonymised patient level data.

Locations

ES(4)FI(9)