Trial Title:
Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
NCT ID:
NCT06328361
Condition:
Rectal Cancer
Rectal Adenocarcinoma
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Nonoperative surveillance
Description:
Clinical and imaging surveillance with digital rectal examination and/or endoscopy,
rectal MRI and body CT
Arm group label:
Nonoperative management
Other name:
Watch and Wait
Other name:
Organ preservation
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
Detailed description:
Background: Non-operative management (NOM) for rectal cancer is an accepted treatment
option that has not been commonly utilized in Finland but has been widely adopted in
major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with
neoadjuvant treatment, resulting in a complete clinical response.
Objective: The aim of the study is to establish a unified NOM protocol for national use
and determine whether the outcomes of Finnish and Estonian treatment practices align with
international experiences.
Design: The study is a prospective, non-randomized, single-arm, international multicenter
trial examining the oncological and quality-of-life consequences of NOM.
Primary Endpoint: The primary endpoint is disease-free survival 2 years after the
initiation of NOM.
Secondary Endpoints: These include overall survival, disease-specific survival, survival
free from total mesorectal excision (TME) surgery, survival free from circulating tumor
DNA (ctDNA) detection after complete clinical response, recurrence-free survival,
incidence of local recurrence and metastases, salvage TME success rate, quality of life
at 1 year post-NOM, and treatment-related morbidity up to 5 years.
Inclusion Criteria: Patients must have histopathologically confirmed primary rectal
adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR)
after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment
after considering the risk of recurrence.
Exclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18,
those not receiving neoadjuvant treatment, or those unable to provide informed consent
are excluded.
Diagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting
inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with
clinical examination, laboratory tests, and imaging.
Randomization: No randomization is performed.
Follow-up: Patients are monitored every 3 months for the first 2 years, then every 6
months for 3 years. Monitoring replaces surgical intervention unless cancer recurs.
Follow-up is part of standard care, with costs covered by the healthcare system.
Safety: Incidence of local recurrence and success of resection post-recurrence are
monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study
termination at the center.
Data Collection: Clinical data are entered into electronic case report forms (eCRFs)
based on primary healthcare documentation and stored pseudonymized on the primary
research center's server. Molecular and pseudonymized clinical data are collected
securely for analysis.
Sample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated
to provide sufficient data for the primary and key secondary endpoints and to meet other
study objectives accurately.
Data Handling: Data handling adheres to privacy legislation, with information stored
pseudonymously.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
East Tallinn Central Hospital
Address:
City:
Tallinn
Country:
Estonia
Status:
Not yet recruiting
Contact:
Last name:
Mihkel Mettis, MD, PhD
Email:
mihkel.mettis@itk.ee
Facility:
Name:
North Estonia Medical Centre
Address:
City:
Tallin
Country:
Estonia
Status:
Not yet recruiting
Contact:
Last name:
Indrek Seire, MD, PhD
Email:
indrek.seire@ut.ee
Facility:
Name:
West Tallinn Central Hospital
Address:
City:
Tallin
Country:
Estonia
Status:
Not yet recruiting
Contact:
Last name:
Kaur Liivak, MD, PhD
Email:
kaur.liivak@keskhaigla.ee
Facility:
Name:
Tartu University Hospital
Address:
City:
Tartu
Country:
Estonia
Status:
Not yet recruiting
Contact:
Last name:
Jaan Soplepman, MD, PhD
Email:
jaan.soplepmann@kliinikum.ee
Facility:
Name:
Helsinki University Central Hospital
Address:
City:
Helsinki
Zip:
00290
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Anna H Lepistö, MD, PhD
Email:
anna.lepisto@hus.fi
Facility:
Name:
North Karelia Central Hospital
Address:
City:
Joensuu
Country:
Finland
Status:
Not yet recruiting
Contact:
Last name:
Markku Matikainen, MD, PhD
Email:
markku.matikainen@siunsote.fi,
Facility:
Name:
Jyväskylä Central Hospital
Address:
City:
Jyväskylä
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Kyösti Tahkola, MD, PhD
Email:
kyosti.tahkola@hyvaks.fi
Facility:
Name:
Kuopio University Hospital
Address:
City:
Kuopio
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Anne Fageström, MD, PhD
Email:
anne.fagerstrom@pshyvinvointialue.fi
Facility:
Name:
Oulu University Hospital
Address:
City:
Oulu
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Karoliina Paarmio, MD, PhD
Email:
karoliina.paarnio@pohde.fi
Facility:
Name:
Satakunta Central Hospital
Address:
City:
Pori
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Jyrki Haikonen, MD, PhD
Email:
jyrki.haikonen@sata.fi
Facility:
Name:
Seinajoki Central Hospital
Address:
City:
Seinäjoki
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Ismo Laitinen, MD, PhD
Email:
ismo.laitinen@hyvaep.fi
Facility:
Name:
Tampere University Hospital
Address:
City:
Tampere
Zip:
33400
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Toni T Seppälä, MD, PhD
Phone:
+358444722846
Email:
toni.seppala@tuni.fi
Facility:
Name:
Turku University Hospital
Address:
City:
Turku
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Pirita Varpe, MD, PhD
Email:
Pirita.Varpe@tyks.fi
Start date:
May 16, 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Tampere University Hospital
Agency class:
Other
Collaborator:
Agency:
Tampere University
Agency class:
Other
Collaborator:
Agency:
Helsinki University Central Hospital
Agency class:
Other
Collaborator:
Agency:
Turku University Hospital
Agency class:
Other
Collaborator:
Agency:
Kuopio University Hospital
Agency class:
Other
Collaborator:
Agency:
Oulu University Hospital
Agency class:
Other
Collaborator:
Agency:
Jyväskylä Central Hospital
Agency class:
Other
Collaborator:
Agency:
Seinajoki Central Hospital
Agency class:
Other
Collaborator:
Agency:
Satakunta Central Hospital
Agency class:
Other
Collaborator:
Agency:
North Karelia Central Hospital
Agency class:
Other
Collaborator:
Agency:
Tartu University Hospital
Agency class:
Other
Collaborator:
Agency:
East Tallinn Central Hospital
Agency class:
Other
Collaborator:
Agency:
West Tallinn Central Hospital
Agency class:
Other
Collaborator:
Agency:
North Estonia Medical Centre
Agency class:
Other
Source:
Tampere University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06328361
