Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer
- Conditions
- Colorectal NeoplasmsDrug Therapy
- Interventions
- Drug: FOLFOXIRI
- Registration Number
- NCT03487939
- Lead Sponsor
- China Medical University, China
- Brief Summary
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal cancer
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- In addition to liver metastases, there are other parts of metastasis
- Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; Active ischemic heart disease; Myocardial infarction within the past 6 months; Symptomatic arrhythmia Uncontrolled hypertension. Unexplained syncope occurred within 3 months
- Gastric ulcers or duodenal ulcers for the treatment of resistance;
- 3 or 4 grade gastrointestinal bleeding / bleeding;
- Gastrointestinal perforation / fistula;
- Abdominal abscess;
- Infectious or inflammatory bowel disease
- HIV infection and/or active hepatitis B virus infection
- Pregnant or lactating women. Fertile patients must use effective contraception
- Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
- Other intervention clinical trials were combined at the same time.
- Nerve or mental abnormality affecting cognitive ability
- Other malignancy except effectively treated squamous cell or basal cell skin cancer,
- Other situations that the researchers think should be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FOLFOXIRI FOLFOXIRI Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.
- Primary Outcome Measures
Name Time Method The ratio of tumor downstaging to stage 0 and stage I 2 years Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
- Secondary Outcome Measures
Name Time Method Tumor regression grade (TRG) 2 years The level of tumor regression under pathological examination
Overall survival time 3 years Estimated from the date of enrollment to death from any cause.
Disease free survival 3 years Estimated from the date of surgery to the date of recurrence.
ctDNA assessment and relation to clinical outcome 3 years The relationship between ctDNA and survival will be evaluated.
SUVmax assessment and relation to clinical outcome At the beginning of Cycle 1 and the end of Cycle 4 (each cycle is 14 days) Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 3 years The grade of toxicity will be assessed using the NCI-CTCAE version 4.0.
Quality of life (QLQ C30) Every 2 weeks after the first treatment until 3 years Scores according to EORTC QLQ-C30 scoring manual
Trial Locations
- Locations (1)
Liaoning cancer hospital
🇨🇳Shenyang, Liaoning, China