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Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Colon Cancer Clinical Trial

Official title:
A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Clinical Trial Summary

A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

Clinical Trial Description

For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.

In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02882269
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact Yueming Sun, PhD
Phone 02568136026
Email jssym@vip.sina.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 2016
Completion date December 2021
View Details
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