colon cancer
Conditions
Interventions
treatment group:FOLFOXIRI regimen
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged > 18 years; 2. Colon adenocarcinoma was confirmed hitologically,or highly atypical hyperplasia was histologically suggested with clear radiological evidence of invasive cancer; 3. Radiological evaluation of preoperative staging of colon cancer should meets one of three criteria: (1) T4, N1-2, M0; (2) Any T stage, N2, M0; (3) CEA > 10 ng/ml; 4. Acute colon ileus was relief after neostomy or stent implantation; 5. WBC > 3.0x10^9/L, PLT > 100x10^9 /L; patient with anemia (Hb 50 ml/min or EDTA clearance rate > 70 ml/min; 7. Enough liver function: total bilirubin(TB) < 25 umol/l.(Patients with Gilbert's syndrome,which have high bilirubin level but hepatic function is normal, are allowed to be included); 8. ECOG performance status score: 0 to 1; 9. For women of childbearing age,it is necessary to: (1) Serum pregnancy test was negative during the first 72 hours of treatment; (2) Agree to use contraception during treatment or for 6 months after treatment; 10. Men with reproductive needs agree to take medically approved and appropriate measures during treatment or within 90 days of the last dose of chemotherapy; 11. Sign an informed consent voluntarily; 12. Patients should indicate willingness and adherence to all study procedures during the study.
Exclusion criteria
Exclusion criteria: 1. Any patients are recommended to accept radiotherapy after MDT; 2. Patients with dMMR and BRAF V600E mutation; 3. Patients with strong evidence of distant or peritoneal nodule (M1) metastasis; 4. Peritonitis (secondary to a perforated tumor); 5. Colonic obstruction that has not resolved its dysfunction; 6. Peripheral neuropathy >= grade 1; 7. Have accepted chemotherapy or targeted therapy before; 8. Serious comorbidities, such as uncontrolled inflammatory bowel disease, uncontrolled angina, or recent (< 6 months) myocardial infarction; 9. Other serious medical conditions that are considered to impair the ability to tolerate neoadjuvant therapy and/or surgery; 10. A history of malignancy other than the colon within the past 5 years, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix or early-stage thyroid cancer; 11. Known allergy to the component of the trial intervention or to some particular component or allergen; 12. Other specific medical conditions (including physical or mental illnesses) or physical abnormalities that make the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Down-staging rate;neoadjuvant toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;3-year treatment failure rate;3-year disease-free survival rate; pathological complete response rate;incidence of surgical complications;long-term quality of life; | — |
Countries
China
Contacts
Public ContactLiren Li
Sun Yat-sen University Cancer Center
Outcome results
None listed