To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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)
Liaoning Cancer Hospital
Shenyang, Liaoning, China
RECRUITINGThe ratio of tumor downstaging to stage 0 and stage I
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Time frame: 2 years
Tumor regression grade (TRG)
The level of tumor regression under pathological examination
Time frame: 2 years
Disease free survival
Estimated from the date of surgery to the date of recurrence
Time frame: 3 years
Overall survival time
Estimated from the date of enrollment to death from any cause
Time frame: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The grade of toxicity will be assessed using the NCI-CTCAE version 4.0
Time frame: 3 years
ctDNA change
The relationship between ctDNA and survival will be evaluated
Time frame: 3 years
SUVmax changes
Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
Time frame: At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Quality of life (QLQ C30)
Scores according to EORTC QLQ-C30 scoring manual
Time frame: Every 2 weeks after the first treatment until 3 years
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