NCT05018182

FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer

To Observe the Pathological Remission Rate and Safety of FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer With a Single-arm, Open, Prospective Phase II Exploratory Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.

Conditions

• High-risk Locally Advanced Colorectal Cancer
• Neoadjuvant Chemotherapy
• FOLFOXIRI Regimen

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery
DRUG	Irinotecan	Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection
DRUG	Folinic Acid	Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection
DRUG	5FU	5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection
DRUG	Capecitabine	Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection

Timeline

• Start date: 2021-08-02
• Primary completion: 2022-04-01
• Completion: 2022-08-02
• First posted: 2021-08-24
• Last updated: 2021-08-24

Locations

1 site across 1 country: China