Clinical trial NCT03009227: Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
Official title: Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms Malignant
Keywords: colon cancer
lymph node dissection
D3 lymph node dissection
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years after last patient enrolled
Secondary outcomes:
measure: Disease-free survival
timeFrame: 5 years after last patient enrolled
measure: Postoperative morbidity
timeFrame: within the first 30 days after surgery
measure: Postoperative mortality
timeFrame: within the first 30 days after surgery
measure: Postoperative recovery parameters
timeFrame: within the first 30 days after surgery
measure: Pattern of lymph node metastasis based on pathology report
timeFrame: enrollment period
measure: CME quality
timeFrame: enrollment period
measure: Lymph node yield
timeFrame: enrollment period
measure: Quality of life in patients after D2 and D3 lymph node dissection using questionnaire
timeFrame: enrollment period
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: Krasnodar City clinical hospital #1
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
city: Moscow
country: Russian Federation
facility: Moscow city oncological hospital #62
city: Moscow
country: Russian Federation
facility: P. Herzen Moscow Oncology Research Institute
city: Obninsk
country: Russian Federation
facility: Medical radiological scientific center named after A.F. Tsyba
city: Rostov
country: Russian Federation
facility: Rostov Research Institute of Oncology
city: Saint Petersburg
country: Russian Federation
facility: St Petersburg City Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)
city: Saint Petersburg
country: Russian Federation
facility: Scientific-Research institute of Oncology named after N.N. Petrov
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Clinic
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Ufa
country: Russian Federation
facility: Republican clinical oncological dispencery
Study officials:
affiliation: N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation
name: Aleksei Karachun, Ph.D.
role: STUDY_CHAIR
References:
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.
citation: 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, 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.