NCT07900620|Not Yet RecruitingDMC
T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
T1LDA
Loading search results
T1LDA
Sponsor study identifier
interventional
500
1 country
14
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2026
Actual (reported)October 28, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
3 years
Recurrence-free survival (RFS)
3 and 5 years
Disease-specific survival (DSS)
3 and 5 years
Participants undergo additional oncologic bowel resection.
Patients undergo follow-up alone without additional treatment.
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.
Kanta-Häme Central Hospital
Hämeenlinna, 13530, Finland
North Carelia Central Hospital
Joensuu, 80210, Finland
Jyväskylä Central Hospital
Jyväskylä, 40620, Finland
Toni T Seppälä, MD, PhD
Tampere University Hospital
First Submitted
October 12, 2026
First Posted
October 28, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 1, 2032
EstimatedColorectal Cancer Screening in the Homeless
Overall survival (OS)
3 and 5 years
Local, distant and overall recurrence
3 and 5 years
Rate of lymph node metastases
3 and 5 years
Contact the study team to confirm eligibility.
Kymenlaakso Central Hospital
Kotka, 48210, Finland
Kuopio University Hospital
Kuopio, 70210, Finland
Päijät-Häme Central Hospital
Lahti, 15850, Finland
Mikkeli Central Hospital
Mikkeli, 50100, Finland
Oulu University Hospital
Oulu, 90220, Finland
Satakunta Central Hospital
Pori, 28500, Finland
Lapland Central Hospital
Rovaniemi, 96400, Finland
Seinäjoki Central Hospital
Seinäjoki, 60220, Finland
Tampere University Hospital
Tampere, 33400, Finland
Turku University Hospital
Turku, 20521, Finland
Vaasa Central Hospital
Vaasa, 65130, Finland
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
Data sharing is not planned due to restrictions related to the European General Data Protection Regulation (GDPR) regarding patient-level data.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: