Colorectal CancerT1LDANCT07900620
T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
A study testing Additional surgery in people with Colorectal Cancer, run by Tampere University Hospital at 14 sites in Finland.
Trial summary
The goal of this two-arm clinical trial is to compare additional surgery with active surveillance in patients with high-risk pT1 colorectal cancer after local excision. The main questions it aims to answer are Does additional surgery result in lower rates of distant or extraluminal recurrence compared with active… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Additional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 14 sitesFinland
- Study dates
- 1 Nov 2026to 1 Nov 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed diagnosis of pT1 colorectal cancer
- Adenocarcinoma treated by endoscopic or transanal local excision
- One to three risk factors for LNM or recurrence present Lymphovascular invasion (LVI) Intermediate or high tumor budding (grade 2-3) Close margin resection, defined as 100-1000 µm histologically non-cancerous resection margin, measured from the closest part of invasive adenocarcinoma to the resection line, without direct adenocarcinoma involvement at the margin The histological margin cannot be reliably assessed due to cautery artifact at the resection margin, where carcinoma is present at the evaluable edge, reflecting the involvement of cancer in margin. However, given the endoscopist's impression of complete excision Piecemeal resection, where the endoscopist's impression is that complete excision has been achieved (unclear resection margin after an endoscopic resection reported to have good macroscopic margin, e.g. a successful piecemeal resection) Adenoma involvement of the resection margin defined as 0 µm WHO high-grade adenocarcinoma Perineural invasion DSI (>1000µm invasion or Haggitt level 4 or Kudo sm3)
- Adequately performed primary colonoscopy, defined as a complete colonoscopy with visualization of the entire rectum and colon up to the cecum and no technical limitations compromising mucosal assessment or exclusion of synchronous disease
- Patient age 18 or more
- ECOG 0-2
Who cannot join
- The patient is not eligible for either surgery or follow-up Multidisciplinary team (MDT) considers the surgical complication risk too high MDT considers the recurrence risk of surveillance strategy too high The patient is unable to understand information provided The patient is not willing to commit to the required follow-up
- Either no high-risk factors are present or four or more high-risk factors are present
- R1 resection, defined as noncancerous margin < 100 µm without cautery artefact and not meeting criteria for piecemeal resection
- Radiological involvement of lymph nodes (N+) in rectal cancer:
- Clearly pathologic nodes or suspicious nodes with additional risk factors, i.e. suspicious if: ≥9 mm or mucinous signal Smaller nodes 5-9 mm: Require 2 additional malignant features for cN+ classification. Nodes <5 mm, unless mucinous, are considered benign.
- Additional malignant features: indistinct LN border or heterogeneous MRI signal
Show all 14Show fewer
- Clear radiological suspicion of malignant lymph nodes in colon cancer size >10 mm
- Radiological or histological EMVI+ (extramural vascular invasion) or radiological TD+ (tumor deposit)
- Actively treated invasive cancer within 2 years
- Any metastatic cancer
- History of previous CRC
- Hereditary CRC syndrome
- Inflammatory bowel disease
- Suspected M1 level metastases
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Finland14 sites
Kanta-Häme Central Hospital
Hämeenlinna, 13530
Arto Turunen, MD, PhD, arto.turunen@omahame.fi
North Carelia Central Hospital
Joensuu, 80210
Markku Matikainen, MD, PhD, markku.matikainen@siunsote.fi
Jyväskylä Central Hospital
Jyväskylä, 40620
Kyösti Tahkola, MD, PhD, kyosti.tahkola@hyvaks.fi
Kymenlaakso Central Hospital
Kotka, 48210
Pälvi Vento, MD, PhD, palvi.vento@kymenhva.fi
Kuopio University Hospital
Kuopio, 70210
Elina Kettunen, MD, elina.kettunen@pshyvinvointialue.fi
Päijät-Häme Central Hospital
Lahti, 15850
Juha Rinne, MD, juha.rinne@paijatha.fi
Mikkeli Central Hospital
Mikkeli, 50100
Kalevi Lehtonen, MD, PhD, kalevi.lehtonen@etelasavonha.fi
Oulu University Hospital
Oulu, 90220
Kirsi Laitakari, MD, PhD, kirsi.laitakari@pohde.fi
Satakunta Central Hospital
Pori, 28500
Hilkka Ryhänen, MD, PhD, hilkka.ryhanen@sata.fi
Lapland Central Hospital
Rovaniemi, 96400
Tuomas Anttila, MD, tuomas.anttila@lapha.fi
Seinäjoki Central Hospital
Seinäjoki, 60220
Ismo Laitinen, MD, PhD, ismo.laitinen@hyvaep.fi
Tampere University Hospital
Tampere, 33400
Toni T Seppälä, MD, PhD, +358444722846, toni.seppala@tuni.fi
Viivi Kaaronen, MD
Turku University Hospital
Turku, 20521
Anu Carpelan, MD, PhD, anu.carpelan@varha.fi
Vaasa Central Hospital
Vaasa, 65130
Joni Leppänen, MD, PhD, joni.leppanen@ovph.fi
About this study
The goal of this two-arm clinical trial is to compare additional surgery with active surveillance in patients with high-risk pT1 colorectal cancer after local excision. The main questions it aims to answer are Does additional surgery result in lower rates of distant or extraluminal recurrence compared with active surveillance? How do the two treatment strategies differ in survival, complications, quality of life, and treatment-related costs?
Participants will be randomly assigned to either additional surgery or active surveillance.
Read more
Patients assigned to the surgery group will undergo standard preoperative assessment followed by additional surgery. Following surgery, patients will undergo surveillance according to the predefined follow-up protocol.
Patients assigned to the active surveillance group will not receive any additional treatment. They will undergo surveillance according to a more intensive predefined follow-up protocol.
Read the detailed description
Finnish and European guidelines recommend additional surgery after local excision of high-risk pT1 colorectal cancer (CRC) because of the risk of lymph node metastases. However, most patients do not have lymph node involvement. As a result, many patients may undergo radical surgery without direct oncological benefit while being exposed to treatment-related morbidity and mortality.
Prospective randomized evidence demonstrating the benefit of additional surgery over active surveillance remains limited.
T1LDA-trial is a national, multicenter, open-label, two-arm randomized superiority trial designed to evaluate treatment of high-risk pT1 colorectal cancer following local excision. The study is coordinated by Tampere University Hospital.
Inclusion criteria: Age ≥18 years, histologically confirmed pT1 colorectal cancer treated by local excision, and the presence of one to three histopathological high-risk factors for lymph node metastasis or recurrence.
Exclusion criteria: Patient is not eligible for either surgery or surveillance, have suspected lymph node involvement or metastatic disease.
Participants are randomly assigned in a 1:1 ratio to either additional surgery or active surveillance. Both groups will follow a predefined follow-up schedule. Eligible patients who do not consent to randomization may participate in a parallel prospective observational cohort. Treatment allocation in the observational cohort is based on patient and physician choice, and participants will be followed according to the study protocol.
The primary endpoint is 3-year distant or extraluminal recurrence within 3 years of study enrollment.
Secondary outcomes include survival outcomes (recurrence-free, disease-specific, and overall survival), recurrence patterns, lymph node metastases, complications, salvage surgery, health-related quality of life, and treatment-related costs.
Eligible patients will be followed up for 5 years according to predefined follow-up protocol. For surveillance group the follow-up protocol is designed to be more intense, according to clinical practice.
Both treatment strategies are based on standard clinical practice, although the majority of patients currently undergo additional surgery. Participants assigned to active surveillance may avoid the risks associated with CRC surgery but may be at higher risk for disease recurrence. Safety will be evaluated throughout the study by recording adverse events, disease recurrence, complications, salvage surgeries, and mortality.
Study data will be collected and recorded in pseudonymized form in an electronic Case Report Form (eCRF) derived from hospital electronic health records. The eCRF is implemented in REDCap and hosted and maintained by Tampere University Hospital.
The target effect size was defined using the smallest worthwhile effect (SWE) framework, based on patient input from the Association of Cancer Patients in Finland and the Finnish Colorectal Cancer Association. The final sample size for the randomized cohort was determined to be 340 participants.
- Conditions
- Colorectal Cancer
- Being tested
- Additional surgery
- Keywords
- Colon Cancer, Rectal Cancer, Gastrointestinal Neoplasms, Local Excision, Additional Surgery, Completion Surgery, Active Surveillance, Organ Preservation, Lymph Node Metastasis, Randomized Trial, Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Gastrointestinal Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional surgeryProcedure or surgery
Patients assigned to the intervention group undergo standard preoperative assessment and preparation, followed by additional oncologic resection of the bowel segment containing the tumor, including the mesentery and regional lymph nodes. The appropriate surgical technique is selected at the discretion of the treating surgeon, based on standard clinical practice and individual patient characteristics. Open, laparoscopic and robotic approaches are all permitted.
| Study group | Role | What they receive |
|---|---|---|
| Additional surgery (intervention group) | Experimental | Participants undergo additional oncologic bowel resection. Receives: Procedure: Additional surgery |
| Active surveillance (control group) | No intervention | Patients undergo follow-up alone without additional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant or extraluminal recurrence rate
The primary endpoint is 3-year distant or extraluminal recurrence, defined as the occurrence of any distant recurrence or extraluminal local recurrence within 3 years of study enrollment.
Measured: 3 years
Secondary outcomes (14)
Recurrence-free survival (RFS)
Time from study enrollment to the first occurrence of confirmed recurrence or colorectal cancer-related death.
Measured: 3 and 5 years
Disease-specific survival (DSS)
Time from study enrollment to confirmed colorectal cancer-specific death. Deaths due to other causes will be treated as censoring events.
Measured: 3 and 5 years
Overall survival (OS)
Time from study enrollment to death from any cause.
Measured: 3 and 5 years
Local, distant and overall recurrence
The proportion of participants with confirmed local (intraluminal or extraluminal) recurrence, distant recurrence or overall recurrence during follow-up. Overall recurrence includes both local and distant recurrences.
Measured: 3 and 5 years
Rate of lymph node metastases
The proportion of participants with histologically confirmed lymph node metastases identified in surgical specimens.
Measured: 3 and 5 years
Predictive value of predefined histopathological high-risk factors for histologically confirmed lymph node metastases.
The predictive value of predefined histopathological high-risk features, including lymphovascular invasion, tumor budding, poor differentiation, and deep submucosal invasion, for histologically confirmed lymph node metastases will be evaluated.
Measured: 5 years
Complication and mortality rates (surgical- and non-surgical)
The proportion of participants experiencing complications or death within 30 and 90 days after treatment allocation. Complications will be graded according to the Clavien-Dindo classification
Measured: 30 and 90 days
Long-term complication rates (surgical- and non-surgical)
The proportion of participants experiencing treatment-related complications occurring more than 90 days after treatment allocation.
Measured: 5 years
Number and characteristics of salvage surgeries
Number of salvage surgical procedures performed during follow-up, including indications and type of surgery.
Measured: 5 years
Re-operation rate
The proportion of participants requiring one or more additional surgical procedures following the initial treatment strategy.
Measured: 3 and 5 years
Costs of treatment
Direct healthcare costs associated with the assigned treatment strategy, including treatment procedures, hospitalizations, follow-up examinations and management of complications.
Measured: 5 years
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better functioning and quality of life for functional and Global Health Status scales, and greater symptom burden for symptom scales.
Measured: 1, 3 and 5 years
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module (EORTC QLQ-CR29)
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module (EORTC QLQ-CR29). Scores range from 0 to 100. Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales.
Measured: 1, 3 and 5 years
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). EQ-5D-5L index values range from below 0 to 1.0, where 1.0 indicates full health and 0.0 indicates a health state equivalent to death. Higher values indicate better health status.
Measured: 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Vaasa Central Hospital, Vaasa, Finland, Kanta-Häme Central Hospital, Päijät Häme Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Lapland Central Hospital, North Karelia Central Hospital, Seinajoki Central Hospital, Pori Central Hospital, Mikkeli Central Hospital, Jyväskylä Central Hospital
- Responsible party
- Sponsor
- Investigators
- Toni T Seppälä, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900620
- Sponsor's protocol ID
- R26074
- Acronym
- T1LDA
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not planned due to restrictions related to the European General Data Protection Regulation (GDPR) regarding patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
- ClinicalTrials.gov ID
- NCT07900620
- Acronym / sponsor ID
- T1LDA / R26074
- Conditions
- Colorectal Cancer
- Keywords
- Colon Cancer, Rectal Cancer, Gastrointestinal Neoplasms, Local Excision, Additional Surgery, Completion Surgery, Active Surveillance, Organ Preservation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Vaasa Central Hospital, Vaasa, Finland, Kanta-Häme Central Hospital, Päijät Häme Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Lapland Central Hospital, North Karelia Central Hospital, Seinajoki Central Hospital, Pori Central Hospital, Mikkeli Central Hospital, Jyväskylä Central Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2036 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this two-arm clinical trial is to compare additional surgery with active surveillance in patients with high-risk pT1 colorectal cancer after local excision. The main questions it aims to answer are Does additional surgery result in lower rates of distant or extraluminal recurrence compared with active surveillance? How do the two treatment strategies differ in survival, complications, quality of life, and treatment-related costs?
Participants will be randomly assigned to either additional surgery or active surveillance.
Patients assigned to the surgery group will undergo standard preoperative assessment followed by additional surgery. Following surgery, patients will undergo surveillance according to the predefined follow-up protocol.
Patients assigned to the active surveillance group will not receive any additional treatment. They will undergo surveillance according to a more intensive predefined follow-up protocol.
Detailed description
Finnish and European guidelines recommend additional surgery after local excision of high-risk pT1 colorectal cancer (CRC) because of the risk of lymph node metastases. However, most patients do not have lymph node involvement. As a result, many patients may undergo radical surgery without direct oncological benefit while being exposed to treatment-related morbidity and mortality.
Prospective randomized evidence demonstrating the benefit of additional surgery over active surveillance remains limited.
T1LDA-trial is a national, multicenter, open-label, two-arm randomized superiority trial designed to evaluate treatment of high-risk pT1 colorectal cancer following local excision. The study is coordinated by Tampere University Hospital.
Inclusion criteria: Age ≥18 years, histologically confirmed pT1 colorectal cancer treated by local excision, and the presence of one to three histopathological high-risk factors for lymph node metastasis or recurrence.
Exclusion criteria: Patient is not eligible for either surgery or surveillance, have suspected lymph node involvement or metastatic disease.
Participants are randomly assigned in a 1:1 ratio to either additional surgery or active surveillance. Both groups will follow a predefined follow-up schedule. Eligible patients who do not consent to randomization may participate in a parallel prospective observational cohort. Treatment allocation in the observational cohort is based on patient and physician choice, and participants will be followed according to the study protocol.
The primary endpoint is 3-year distant or extraluminal recurrence within 3 years of study enrollment.
Secondary outcomes include survival outcomes (recurrence-free, disease-specific, and overall survival), recurrence patterns, lymph node metastases, complications, salvage surgery, health-related quality of life, and treatment-related costs.
Eligible patients will be followed up for 5 years according to predefined follow-up protocol. For surveillance group the follow-up protocol is designed to be more intense, according to clinical practice.
Both treatment strategies are based on standard clinical practice, although the majority of patients currently undergo additional surgery. Participants assigned to active surveillance may avoid the risks associated with CRC surgery but may be at higher risk for disease recurrence. Safety will be evaluated throughout the study by recording adverse events, disease recurrence, complications, salvage surgeries, and mortality.
Study data will be collected and recorded in pseudonymized form in an electronic Case Report Form (eCRF) derived from hospital electronic health records. The eCRF is implemented in REDCap and hosted and maintained by Tampere University Hospital.
The target effect size was defined using the smallest worthwhile effect (SWE) framework, based on patient input from the Association of Cancer Patients in Finland and the Finnish Colorectal Cancer Association. The final sample size for the randomized cohort was determined to be 340 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional surgery (intervention group) | Experimental | Procedure: Additional surgeryParticipants undergo additional oncologic bowel resection. |
| Active surveillance (control group) | No intervention | –Patients undergo follow-up alone without additional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed diagnosis of pT1 colorectal cancer
- Adenocarcinoma treated by endoscopic or transanal local excision
- One to three risk factors for LNM or recurrence present Lymphovascular invasion (LVI) Intermediate or high tumor budding (grade 2-3) Close margin resection, defined as 100-1000 µm histologically non-cancerous resection margin, measured from the closest part of invasive adenocarcinoma to the resection line, without direct adenocarcinoma involvement at the margin The histological margin cannot be reliably assessed due to cautery artifact at the resection margin, where carcinoma is present at the evaluable edge, reflecting the involvement of cancer in margin. However, given the endoscopist's impression of complete excision Piecemeal resection, where the endoscopist's impression is that complete excision has been achieved (unclear resection margin after an endoscopic resection reported to have good macroscopic margin, e.g. a successful piecemeal resection) Adenoma involvement of the resection margin defined as 0 µm WHO high-grade adenocarcinoma Perineural invasion DSI (>1000µm invasion or Haggitt level 4 or Kudo sm3)
- Adequately performed primary colonoscopy, defined as a complete colonoscopy with visualization of the entire rectum and colon up to the cecum and no technical limitations compromising mucosal assessment or exclusion of synchronous disease
- Patient age 18 or more
Key exclusion criteria (14 listed)
- The patient is not eligible for either surgery or follow-up Multidisciplinary team (MDT) considers the surgical complication risk too high MDT considers the recurrence risk of surveillance strategy too high The patient is unable to understand information provided The patient is not willing to commit to the required follow-up
- Either no high-risk factors are present or four or more high-risk factors are present
- R1 resection, defined as noncancerous margin < 100 µm without cautery artefact and not meeting criteria for piecemeal resection
- Radiological involvement of lymph nodes (N+) in rectal cancer:
- Clearly pathologic nodes or suspicious nodes with additional risk factors, i.e. suspicious if: ≥9 mm or mucinous signal Smaller nodes 5-9 mm: Require 2 additional malignant features for cN+ classification. Nodes <5 mm, unless mucinous, are considered benign.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional surgeryPatients assigned to the intervention group undergo standard preoperative assessment and preparation, followed by additional oncologic resection of the bowel segment containing the tumor, including the mesentery and regional lymph nodes. The appropriate surgical technique is selected at the discretion of the treating surgeon, based on standard clinical practice and individual patient characteristics. Open, laparoscopic and robotic approaches are all permitted. | Procedure or surgery | Additional surgery (intervention group) |
Primary outcome
Distant or extraluminal recurrence rate
Time frame: 3 years
The primary endpoint is 3-year distant or extraluminal recurrence, defined as the occurrence of any distant recurrence or extraluminal local recurrence within 3 years of study enrollment.
14 secondary outcomes
Recurrence-free survival (RFS)
Time frame: 3 and 5 years
Disease-specific survival (DSS)
Time frame: 3 and 5 years
Overall survival (OS)
Time frame: 3 and 5 years
Local, distant and overall recurrence
Time frame: 3 and 5 years
Rate of lymph node metastases
Time frame: 3 and 5 years
Predictive value of predefined histopathological high-risk factors for histologically confirmed lymph node metastases.
Time frame: 5 years
Complication and mortality rates (surgical- and non-surgical)
Time frame: 30 and 90 days
Long-term complication rates (surgical- and non-surgical)
Time frame: 5 years
Number and characteristics of salvage surgeries
Time frame: 5 years
Re-operation rate
Time frame: 3 and 5 years
Costs of treatment
Time frame: 5 years
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: 1, 3 and 5 years
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module (EORTC QLQ-CR29)
Time frame: 1, 3 and 5 years
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: 1, 3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. Data sharing is not planned due to restrictions related to the European General Data Protection Regulation (GDPR) regarding patient-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Toni T Seppälä, MD, PhD principal investigator
Tampere University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional surgery in people with Colorectal Cancer, run by Tampere University Hospital at 14 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viivi Kaaronen, MD (+358504366924, viivi.kaaronen@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant or extraluminal recurrence rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.