Clinical trial · Interventional
Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
NCT03009227CI-TRIAL-00057966COLDunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms Malignant | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonic resection with D2 lymph node dissection | Procedure | — | UNRESOLVED |
| Colonic resection with D3 lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- D2 lymph node dissection
- description
- Colonic resection with D2 lymph node dissection
- interventionNames
- Procedure: Colonic resection with D2 lymph node dissection
- type
- EXPERIMENTAL
- label
- D3 lymph node dissection
- description
- Colonic resection with D3 lymph node dissection
- interventionNames
- Procedure: Colonic resection with D3 lymph node dissection
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 years after last patient enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid) * clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable) * indications for surgical colonic resection * ECOG status 0-2 * At least 18 years of age * Written informed consent Exclusion Criteria: * Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * Pregnancy or breast feeding * Medical contraindications for surgical treatment * Synchronous or metachronous malignancy * Non-resectable distant metastases * Colon obstruction, perforation or bleeding complicating the tumor * Indications for isolated transverse colon resection * Neoadjuvant chemotherapy
References
Publications (2)
- BACKGROUNDKarachun A, Petrov A, Panaiotti L, Voschinin Y, Ovchinnikova T. Protocol for a multicentre randomized clinical trial comparing oncological outcomes of D2 versus D3 lymph node dissection in colonic cancer (COLD trial). BJS Open. 2019 Mar 14;3(3):288-298. doi: 10.1002/bjs5.50142. eCollection 2019 Jun. PMID 31183444
- RESULTKarachun A, Panaiotti L, Chernikovskiy I, Achkasov S, Gevorkyan Y, Savanovich N, Sharygin G, Markushin L, Sushkov O, Aleshin D, Shakhmatov D, Nazarov I, Muratov I, Maynovskaya O, Olkina A, Lankov T, Ovchinnikova T, Kharagezov D, Kaymakchi D, Milakin A, Petrov A. Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial). Br J Surg. 2020 Apr;107(5):499-508. doi: 10.1002/bjs.11387. Epub 2019 Dec 24. PMID 31872869