Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer (COLD)

N.N. Petrov National Medical Research Center of Oncology

Status: Active, not recruiting

Conditions: Colonic Neoplasms Malignant

Treatments: Procedure: Colonic resection with D2 lymph node dissection; Procedure: Colonic resection with D3 lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03009227

COL-1

Details and patient eligibility

About

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

Full description

The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization.

Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-edited video-recordings of procedures.

Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen.

After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol.

This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%.

The intent-to-treat principle is used for the data analysis.

Enrollment: 780 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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780 participants in 2 patient groups

D2 lymph node dissection

Active Comparator group

Description:

Colonic resection with D2 lymph node dissection

Treatment:

Procedure: Colonic resection with D2 lymph node dissection

D3 lymph node dissection

Experimental group

Description:

Colonic resection with D3 lymph node dissection

Treatment:

Procedure: Colonic resection with D3 lymph node dissection