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

Colonic Neoplasms Malignant Clinical Trial

— COLD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03009227
• Other study ID #: COL-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: January 2025

Study information

• Verified date: April 2022
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 780
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Neoplasms Malignant
• Neoplasms

Intervention

Procedure:
• Colonic resection with D2 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
• Colonic resection with D3 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection

Locations

Country	Name	City	State
Russian Federation	Krasnodar City clinical hospital #1	Krasnodar
Russian Federation	Moscow city oncological hospital #62	Moscow
Russian Federation	P. Herzen Moscow Oncology Research Institute	Moscow
Russian Federation	State Scientific Centre of Coloproctology	Moscow
Russian Federation	Medical radiological scientific center named after A.F. Tsyba	Obninsk
Russian Federation	Rostov Research Institute of Oncology	Rostov
Russian Federation	Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)	Saint Petersburg
Russian Federation	Saint-Petersburg State University Clinic	Saint Petersburg
Russian Federation	Scientific-Research institute of Oncology named after N.N. Petrov	Saint Petersburg
Russian Federation	St Petersburg City Clinical Oncology Dispensary	Saint Petersburg
Russian Federation	Pavlov First Saint Petersburg State Medical University	Saint-Petersburg
Russian Federation	Republican clinical oncological dispencery	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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, Pe — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	overall survival of patients	5 years after last patient enrolled
Secondary	Disease-free survival	Survival without local or systemic recurrence	5 years after last patient enrolled
Secondary	Postoperative morbidity	Complications after surgery	within the first 30 days after surgery
Secondary	Postoperative mortality	Death after surgery	within the first 30 days after surgery
Secondary	Postoperative recovery parameters	Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)	within the first 30 days after surgery
Secondary	Pattern of lymph node metastasis based on pathology report	Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen	enrollment period
Secondary	CME quality	Ratio of good, satisfactory and unsatisfactory quality according to pathology report	enrollment period
Secondary	Lymph node yield	Number of lymph nodes removed according to pathology report	enrollment period
Secondary	Quality of life in patients after D2 and D3 lymph node dissection using questionnaire	CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer	enrollment period