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Trial record 61 of 1002 for:    colon cancer AND resection

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

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ClinicalTrials.gov Identifier: NCT03009227
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Malignant Procedure: Colonic resection with D2 lymph node dissection Procedure: Colonic resection with D3 lymph node dissection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years after last patient enrolled ]
    overall survival of patients


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years after last patient enrolled ]
    Survival without local or systemic recurrence

  2. Postoperative morbidity [ Time Frame: within the first 30 days after surgery ]
    Complications after surgery

  3. Postoperative mortality [ Time Frame: within the first 30 days after surgery ]
    Death after surgery

  4. 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.)

  5. 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

  6. CME quality [ Time Frame: enrollment period ]
    Ratio of good, satisfactory and unsatisfactory quality according to pathology report

  7. Lymph node yield [ Time Frame: enrollment period ]
    Number of lymph nodes removed according to pathology report

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 or metachronous malignancy
  • Non-resectable distant metastases
  • Colon obstruction, perforation or bleeding complicating the tumor
  • Indications for isolated transverse colon resection
  • Neoadjuvant chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009227


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

Locations
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Russian Federation
State Scientific Centre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Contact: Sergei Achkasov       achkasovy@mail.ru   
Principal Investigator: Sergei Achkasov         
P. Herzen Moscow Oncology Research Institute Recruiting
Moscow, Russian Federation, 125284
Contact: Dmitrii Sidorov    +7(495) 150 11 22    dvsidorov_65@mail.ru   
Rostov Research Institute of Oncology Recruiting
Rostov, Russian Federation, 344037
Contact: Yuriy Gevorkyan       gevorkyan.000@mail.ru   
Principal Investigator: Yuriy Gevorkyan         
Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology) 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         
Saint-Petersburg State University Clinic Recruiting
Saint Petersburg, Russian Federation, 198103
Contact: Andrey Pavlenko       andrewpavlenko@yandex.ru   
Sponsors and Collaborators
N.N. Petrov National Medical Research Center of Oncology
Investigators
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Study Chair: Aleksei Karachun, Ph.D. N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation

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Responsible Party: N.N. Petrov National Medical Research Center of Oncology
ClinicalTrials.gov Identifier: NCT03009227     History of Changes
Other Study ID Numbers: COL-1
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not planning to share personal patient data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by N.N. Petrov National Medical Research Center of Oncology:
colon cancer
lymph node dissection
D3 lymph node dissection
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases