NCT03484195

Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.

Detailed description

For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer. In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.

Conditions

• Colonic Neoplasms
• Drug Therapy

Interventions

Type	Name	Description
DRUG	FOLFOXIRI	Irinotecan 150 mg/m\^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m\^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m\^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m\^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2018-03-30
• Last updated: 2021-04-19

Locations

1 site across 1 country: China