Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

NCT ID: NCT03009227

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2025-01-31

Brief Summary

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

Detailed 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.

Conditions

Colonic Neoplasms Malignant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D2 lymph node dissection

Colonic resection with D2 lymph node dissection

Group Type: ACTIVE_COMPARATOR

Colonic resection with D2 lymph node dissection

Intervention Type: PROCEDURE

Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection

D3 lymph node dissection

Colonic resection with D3 lymph node dissection

Group Type: EXPERIMENTAL

Colonic resection with D3 lymph node dissection

Intervention Type: PROCEDURE

Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection

Interventions

Colonic resection with D2 lymph node dissection

Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection

Intervention Type: PROCEDURE

Colonic resection with D3 lymph node dissection

Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

N.N. Petrov National Medical Research Center of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksei Karachun, Ph.D.

Role: STUDY_CHAIR

N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation

Locations

Krasnodar City clinical hospital #1

Krasnodar, , Russia

State Scientific Centre of Coloproctology

Moscow, , Russia

Moscow city oncological hospital #62

Moscow, , Russia

P. Herzen Moscow Oncology Research Institute

Moscow, , Russia

Medical radiological scientific center named after A.F. Tsyba

Obninsk, , Russia

Rostov Research Institute of Oncology

Rostov, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

St Petersburg City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)

Saint Petersburg, , Russia

Scientific-Research institute of Oncology named after N.N. Petrov

Saint Petersburg, , Russia

Saint-Petersburg State University Clinic

Saint Petersburg, , Russia

Republican clinical oncological dispencery

Ufa, , Russia

Countries

Russia

References

Karachun 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.

Reference Type: BACKGROUND

PMID: 31183444 (View on PubMed)

Karachun 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.

Reference Type: RESULT

PMID: 31872869 (View on PubMed)

Other Identifiers

COL-1

Identifier Type: -

Identifier Source: org_study_id