Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06328361 |
| Other study ID # |
R24008 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
December 31, 2032 |
Study information
| Verified date |
April 2024 |
| Source |
Tampere University Hospital |
| Contact |
Toni T Seppälä, MD, PhD |
| Phone |
+358444722846 |
| Email |
toni.seppala[@]tuni.fi |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
