Colonic Neoplasms MalignantCOLDNCT03009227
Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
A study testing Colonic resection with D2 lymph node dissection and Colonic resection with D3 lymph node dissection in people with Colonic Neoplasms Malignant, run by N.N. Petrov National Medical Research Center of Oncology at 12 sites in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms Malignant
- What is being tested?
- Colonic resection with D2 lymph node dissection and Colonic resection with D3 lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 12 sitesRussia
- Study dates
- 3 Feb 2017to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Krasnodar City clinical hospital #1
Krasnodar, 350000
State Scientific Centre of Coloproctology
Moscow, 123423
Moscow city oncological hospital #62
Moscow, 125130
P. Herzen Moscow Oncology Research Institute
Moscow, 125284
Medical radiological scientific center named after A.F. Tsyba
Obninsk, 450054
Rostov Research Institute of Oncology
Rostov-on-Don, 344037
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022
St Petersburg City Clinical Oncology Dispensary
Saint Petersburg, 197022
Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)
Saint Petersburg, 197758
Scientific-Research institute of Oncology named after N.N. Petrov
Saint Petersburg, 197758
Saint-Petersburg State University Clinic
Saint Petersburg, 198103
Republican clinical oncological dispencery
Ufa, 450054
About this study
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
Read the 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
- Being tested
- Colonic resection with D2 lymph node dissection, Colonic resection with D3 lymph node dissection
- Keywords
- colon cancer, lymph node dissection, D3 lymph node dissection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic resection with D2 lymph node dissectionProcedure or surgery
Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
Colonic resection with D3 lymph node dissectionProcedure or surgery
Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| D2 lymph node dissection | Active comparator | Colonic resection with D2 lymph node dissection Receives: Procedure: Colonic resection with D2 lymph node dissection |
| D3 lymph node dissection | Experimental | Colonic resection with D3 lymph node dissection Receives: Procedure: Colonic resection with D3 lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
overall survival of patients
Measured: 5 years after last patient enrolled
Secondary outcomes (8)
Disease-free survival
Survival without local or systemic recurrence
Measured: 5 years after last patient enrolled
Postoperative morbidity
Complications after surgery
Measured: within the first 30 days after surgery
Postoperative mortality
Death after surgery
Measured: within the first 30 days after surgery
Postoperative recovery parameters
Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)
Measured: within the first 30 days after surgery
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
Measured: enrollment period
CME quality
Ratio of good, satisfactory and unsatisfactory quality according to pathology report
Measured: enrollment period
Lymph node yield
Number of lymph nodes removed according to pathology report
Measured: enrollment period
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
Measured: enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start3 Feb 2017
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksei Karachun, Ph.D., Study chair, N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009227
- Sponsor's protocol ID
- COL-1
- Acronym
- COLD
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2016
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share personal patient data
Publications
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.
PubMed 31183444Karachun 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.
PubMed 31872869
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
- ClinicalTrials.gov ID
- NCT03009227
- Acronym / sponsor ID
- COLD / COL-1
- Conditions
- Colonic Neoplasms Malignant
- Keywords
- colon cancer, lymph node dissection, D3 lymph node dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (actual)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 lymph node dissection | Active comparator | Procedure: Colonic resection with D2 lymph node dissectionColonic resection with D2 lymph node dissection |
| D3 lymph node dissection | Experimental | Procedure: Colonic resection with D3 lymph node dissectionColonic resection with D3 lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic resection with D2 lymph node dissectionAppropriate to the tumor location colonic resection is performed with D2 lymph node dissection | Procedure or surgery | D2 lymph node dissection |
| Colonic resection with D3 lymph node dissectionAppropriate to the tumor location colonic resection is performed with D3 lymph node dissection | Procedure or surgery | D3 lymph node dissection |
Primary outcome
Overall survival
Time frame: 5 years after last patient enrolled
overall survival of patients
8 secondary outcomes
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
Pattern of lymph node metastasis based on pathology report
Time frame: enrollment period
CME quality
Time frame: enrollment period
Lymph node yield
Time frame: enrollment period
Quality of life in patients after D2 and D3 lymph node dissection using questionnaire
Time frame: enrollment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Background: PubMed 31183444Karachun 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.
- Results publication: PubMed 31872869Karachun 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.
- Individual participant dataSharing planned: No. We are not planning to share personal patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksei Karachun, Ph.D. study chair
N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonic resection with D2 lymph node dissection and Colonic resection with D3 lymph node dissection in people with Colonic Neoplasms Malignant, run by N.N. Petrov National Medical Research Center of Oncology at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years after last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.