NCT03125980

Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,370 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.

Conditions

• Locally Advanced Colon Cancer

Interventions

Type	Name	Description
DRUG	capecitabine plus oxaliplatin before and after surgery	Subjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows: 1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 3. Repeat every 3 weeks (Q3W)
DRUG	capecitabine plus oxaliplatin after surgery	Subjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows: 1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 3. Q3W

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-05-01
• Completion: 2027-05-01
• First posted: 2017-04-24
• Last updated: 2017-04-24

Locations

1 site across 1 country: China