NCT06652672 Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
| NCT ID | NCT06652672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meander Medical Center |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 341 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2030-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 341 participants in total. It began in 2024-12-12 with a primary completion date of 2030-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the tumor or scar, along with sentinel node (SLN) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.
Eligibility Criteria
Inclusion Criteria: * Oral and written informed consent (IC) * Aged 18 years and older * Fit for both organ-sparing surgery and colectomy * Pathologically confirmed T1-2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk \>15% (Table 5.2.2. in module 5.2 of the Dutch CRC guideline); or a lesion macroscopically suspected to be (deep-invasive) T1 colon cancer, measuring \<40 mm, for which wedge resection is considered the most suitable local resection technique as recommended by the MDT * The resection scar after local excision is expected to be clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colorectal segment where no other polypectomies were performed * Lesion located \>25cm from the anus based on endoscopic measurement, or above sigmoid take-off Exclusion Criteria: * Patients who opt for active follow-up instead of surgery following shared decision-making * Distant metastasis * Lynch syndrome * Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis * Previous colorectal cancer within the last 5 years * Tumours that comprised \>50% of the colon circumference before resection * Tumours involving the ileocaecal valve * Pregnancy, lactation or a planned pregnancy during the course of the study * Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide) * Previous colonic surgery (excluding appendectomy) * Contra-indication for laparoscopic or robotic surgery * Severe kidney- or liver failure * Hyperthyroidism or an autonomously functioning thyroid adenoma
Contact & Investigator
Frank J Voskens
PRINCIPAL INVESTIGATOR
Meander Medical Center
Frequently Asked Questions
Who can join the NCT06652672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06652672 currently recruiting?
Yes, NCT06652672 is actively recruiting participants. Contact the research team at bct.vande.laar@meandermc.nl for enrollment information.
Where is the NCT06652672 trial being conducted?
This trial is being conducted at Amersfoort, Netherlands.
Who is sponsoring the NCT06652672 clinical trial?
NCT06652672 is sponsored by Meander Medical Center. The principal investigator is Frank J Voskens at Meander Medical Center. The trial plans to enroll 341 participants.
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