To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal cancer
For the patients Neoadjuvant FOLFOX chemotherapy is recommended for the resectable liver metastasis colorectal cancer. Neoadjuvant chemotherapy could suppress tumor, reduce metastasis, inhibit recurrence and improve long-term prognosis. Moreover, neoadjuvant chemotherapy could provide evidence about tumor response to drugs for the adjuvant chemotherapy. Furthermore, according to the biological behavior of tumors observed by neoadjuvant chemotherapy, unnecessarily excessive surgery could be avoided. However, some studies suggested that drug efficiency was consistent with resection rate. And FOLFOXIRI has been observed efficacy in the treatment of metastatic colorectal cancer with manageable toxicities. Therefore, we evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy in the patients with resectable liver metastasis of colorectal cancer to achieve higher resection rate and longer survival. In this prospective study, 30 patients with resectable colorectal liver metastases were treated with neoadjuvant FOLFOXIRI chemotherapy. After 4 cycles of neoadjuvant chemotherapy, the liver metastases will be removed. If there are primary bowel lesions, they will be resected together. Safety profile was recorded based on NCI Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0). Objective response was evaluated by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Before treatment and after 4 cycles of neoadjuvant chemotherapy, we will evaluate tumor metabolic response via FDG-PET and monitor the dynamic changes of peripheral blood ctDNA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
IRINOTECAN 150 mg/m\^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m\^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m\^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m\^2 IV 48-h 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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The grade of toxicity will be assessed using the NCI-CTCAE version 4.0.
Time frame: 3 years
ctDNA assessment and relation to clinical outcome
The relationship between ctDNA and survival will be evaluated.
Time frame: 3 years
SUVmax assessment and relation to clinical outcome
Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
Time frame: At the beginning 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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