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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03200834
Other study ID # 0001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 25, 2017
Est. completion date January 3, 2029

Study information

Verified date November 2023
Source G.V. Bondar Republican Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 239
Est. completion date January 3, 2029
Est. primary completion date January 3, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Agreement of the patient to participate in trial 2. Colon cancer (only adenocarcinoma ) 3. The tumor located between the cecum and the right 1/3 of transverse colon 4. Tumors T3,?4?,b N0-2 (II-III stages) 5. Tolerance of chemotherapy 6. ECOG 0-2 Exclusion Criteria: 1. Patients with distant metastases 2. Tumors T1-2 (I stage) 3. Complications of tumor (perforation and full bowel obstruction) 4. Previous radiotherapy or chemotherapy 5. Synchronous or metachronous tumors 6. Women during Pregnancy or breast feeding period

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Right Hemicolectomy with D2 lymph node dissection
Remove right part of colon with lymph node dissection ?201, ?202, ?211, ?212 (if present), ?221,?222 (Japanese classification).
Right Hemicolectomy with D3 lymph node dissection
Remove right part of colon with lymph node dissection ?201, ?202, ? 203, ?211, ?212 (if present), ?213 (if present) ?221,?222, ?223 (for hepatic flexure and proximal part of transverse colon cancer)(Japanese classification).

Locations

Country Name City State
Ukraine G.V. Bondar Republican Cancer Center Donetsk

Sponsors (3)

Lead Sponsor Collaborator
G.V. Bondar Republican Cancer Center Donetsk National Medical University, I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5-year survival death from any cause Up to 5 years post-operative
Secondary morbidity postoperative complications within the first 30 days after surgery
Secondary mortality death after surgery within the first 30 days after surgery
Secondary Disease free survival 5 years after initial surgery local and distant metastasis during 5 years after operation Up to 5 years post-operative
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