Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

Study Overview
=================
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.

Official Title
-----------------
Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

Conditions
-----------------
Colonic Neoplasms Malignant

Intervention / Treatment
-----------------
* Procedure: Colonic resection with D2 lymph node dissection
* Procedure: Colonic resection with D3 lymph node dissection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D2 lymph node dissection<br>Colonic resection with D2 lymph node dissection | Procedure: Colonic resection with D2 lymph node dissection<br>* Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection<br>|
| Experimental: D3 lymph node dissection<br>Colonic resection with D3 lymph node dissection | Procedure: Colonic resection with D3 lymph node dissection<br>* Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | overall survival of patients | 5 years after last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Survival without local or systemic recurrence | 5 years after last patient enrolled | 
| Postoperative morbidity | Complications after surgery | within the first 30 days after surgery | 
| Postoperative mortality | Death after surgery | 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.) | 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 | enrollment period | 
| CME quality | Ratio of good, satisfactory and unsatisfactory quality according to pathology report | enrollment period | 
| Lymph node yield | Number of lymph nodes removed according to pathology report | 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 | enrollment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon cancer, lymph node dissection, D3 lymph node dissection