Colonic Neoplasms Malignant
Conditions
Keywords
colon cancer, lymph node dissection, D3 lymph node dissection
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.
Interventions
PROCEDUREColonic resection with D2 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
PROCEDUREColonic resection with D3 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years after last patient enrolled | overall survival of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | within the first 30 days after surgery | Complications after surgery |
| Postoperative mortality | within the first 30 days after surgery | Death 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.) |
| Disease-free survival | 5 years after last patient enrolled | Survival without local or systemic recurrence |
| CME quality | enrollment period | Ratio of good, satisfactory and unsatisfactory quality according to pathology report |
| Lymph node yield | enrollment period | Number of lymph nodes removed according to pathology report |
| 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 |
| 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 |
Countries
Russia
Outcome results
None listed