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

Not Applicable

Active, not recruiting

• Conditions: Colonic Neoplasms Malignant

• Registration Number: NCT03009227
• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology

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.

Study Timeline

• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Study Start: 2017-02-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-21
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 780

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years after last patient enrolled	overall survival of patients

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Krasnodar City clinical hospital #1; 🇷🇺 Krasnodar, Russian Federation

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation

Moscow city oncological hospital #62; 🇷🇺 Moscow, Russian Federation

P. Herzen Moscow Oncology Research Institute; 🇷🇺 Moscow, Russian Federation

Medical radiological scientific center named after A.F. Tsyba; 🇷🇺 Obninsk, Russian Federation

Rostov Research Institute of Oncology; 🇷🇺 Rostov, Russian Federation

St Petersburg City Clinical Oncology Dispensary; 🇷🇺 Saint Petersburg, Russian Federation

Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology); 🇷🇺 Saint Petersburg, Russian Federation

Scientific-Research institute of Oncology named after N.N. Petrov; 🇷🇺 Saint Petersburg, Russian Federation

Saint-Petersburg State University Clinic; 🇷🇺 Saint Petersburg, Russian Federation

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