Minimally invasive surgery for early-stage colon cancer
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
This study is testing a new, less invasive surgery for early-stage colon cancer to see if it can lower the chances of cancer coming back compared to the standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 341 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Meander Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amersfoort) |
| Trial ID | NCT06652672 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce the need for extensive segmental colonic resections in patients with high-risk pT1 and low-risk pT2 colon cancer by utilizing endoscopic-assisted laparoscopic or robotic wedge resection combined with sentinel node biopsy using indocyanine green (ICG). The approach will be compared to the standard segmental resection in a partially randomized patient preference design. The primary outcome measured will be the 3-year recurrence rate of cancer. This innovative method seeks to minimize surgical morbidity and improve patient quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed high-risk T1 or low-risk T2 adenocarcinoma of the colon who are fit for both organ-sparing surgery and colectomy.
Not a fit: Patients with distant metastasis, mucinous or signet ring cell carcinoma, or those with Lynch syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the complications associated with traditional colon cancer surgeries while maintaining effective cancer treatment.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in reducing surgical morbidity in early-stage cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amersfoort
- Meander Medisch Centrum — Amersfoort, Netherlands (Recruiting)
Study contacts
- Principal investigator: Frank J Voskens — Meander Medical Center
- Study coordinator: Bart CT van de Laar
- Email: bct.vande.laar@meandermc.nl
- Phone: +31338507137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.