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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Petrov Research Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier:
NCT03009227
First received: December 29, 2016
Last updated: January 19, 2017
Last verified: January 2017
  Purpose
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

Condition Intervention
Colonic Neoplasms Malignant
Procedure: Colonic resection with D2 lymph node dissection
Procedure: Colonic resection with D3 lymph node dissection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

Resource links provided by NLM:


Further study details as provided by Petrov Research Institute of Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years after last patient enrolled ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 years after last patient enrolled ]
  • Postoperative morbidity [ Time Frame: within the first 30 days after surgery ]
  • Postoperative mortality [ Time Frame: within the first 30 days after surgery ]
  • Postoperative recovery parameters [ Time Frame: within the first 30 days after surgery ]
    Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)

  • Open and laparoscopic interventions ratio [ Time Frame: enrollment period ]
  • Pattern of lymph node metastasis based on pathology report [ Time Frame: enrollment period ]
    Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen

  • Complete mesocolic excision quality in open and laparoscopic procedures based on pathology report [ Time Frame: enrollment period ]
    Plane of dissection will be described by pathology report (mesocolic plane, intramesocolic plan and muscular is propria plane), determing the quality of complete mesocolic excision.

  • Lymph node dissection quality in open and laparoscopic procedures based on surgery report and attached photos [ Time Frame: enrollment period ]
    Percentage of cases, in which the desired level of dissection was achieved in open and laparoscopic procedures will be compared

  • Quality of life in patients after D2 and D3 lymph node dissection using questionnaire [ Time Frame: enrollment period ]
    CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer


Estimated Enrollment: 768
Study Start Date: January 2017
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: D2 lymph node dissection
Colonic resection with D2 lymph node dissection
Procedure: Colonic resection with D2 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
Experimental: D3 lymph node dissection
Colonic resection with D3 lymph node dissection
Procedure: Colonic resection with D3 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection

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-editted 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 malignancy
  • Non-resectable distant metastases
  • Colon obstruction, perforation or bleeding complicating the tumor
  • Indications for isolated transverse colon resection
  • Neoadjuvant chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03009227

Contacts
Contact: Aleksei Petrov +79214117866 alexpetrov@doctor.com
Contact: Aleksei Karachun, Ph.D. +79219462123 dr.a.karachun@gmail.com

Locations
Russian Federation
N.N. Blokhin Russian Cancer Research Center Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Arsen Rasulov, Ph.D.       arsen69@list.ru   
Principal Investigator: Arsen Rasulov, Ph.D.         
Saint-Petersburg Clinical Research and Practical Center of Specialized Types of Medical Care (Oncological) Not yet recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Ilya Chernikovskiy       odindra@mail.ru   
Principal Investigator: Ilya Chernikovskiy         
Scientific-Research institute of Oncology named after N.N. Petrov Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Aleksei Petrov    +79214117866    alexpetrov@doctor.com   
Principal Investigator: Aleksei Karachun         
Sub-Investigator: Aleksei Petrov         
Sponsors and Collaborators
Petrov Research Institute of Oncology
Investigators
Study Chair: Aleksei Karachun, Ph.D. N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation
  More Information

Responsible Party: Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT03009227     History of Changes
Other Study ID Numbers: COL-1 
Study First Received: December 29, 2016
Last Updated: January 19, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: We are not planning to share personal patient data

Keywords provided by Petrov Research Institute of Oncology:
colon cancer
lymph node dissection
D3 lymph node dissection

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on February 20, 2017