Cetuximab, Neoadjuvant Treatment, Radiotherapy, Rectal Cancer
Conditions
Brief summary
Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer
Interventions
DRUGcetuximab+mFOLFOX6
cetuximab 500mg/m2 d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles
RADIATIONshort-course radiotherapy
25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6
Sponsors
Shanghai Minimally Invasive Surgery Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. A biopsy proven histological diagnosis of rectal adenocarcinoma； 2. An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type; 3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT; 4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer; 5. Age between 18-75 years; 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1; 7. Has sufficient organ function: * Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, neutrophils ≥ 1.5 × 109/L * Liver function: ALT and AST \< 2.5 × ULN; * Renal function: serum creatinine \< 1.5 ULN; 8. Willing to participate and informed consent signed；
Exclusion criteria
1. Patients with mutations in any of KRAS, NRAS, or BRAF, microsatellite instablility-High; 2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer; 3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ; 4. Female patients who are pregnant or breastfeeding; 5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease; 6. Patients with active infection; 7. Poor overall health status, ECOG ≥ 2; 8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator; 9. Known hypersensitivity reactions to any investigational drugs;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | two weeks after surgery | Tumor Regression Grade 0-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year metastasis-free rate 2-year distant metastasis free rate | 2 years after enrollment | Refers to the probability of no distant metastasis within 2 years |
| Overall survival | 2 years after enrollment | Refers to the time from the start of treatment to death due to any cause. |
| disease-free survival | 2 years after enrollment | Refers to the time from the start of treatment to recurrence. |
| Pathological complete response rate | two weeks after surgery | Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0) |
| 2-year local control rate | 2 years after enrollment | Refers to the probability of not finding local recurrence of tumor within 2 years，including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit. |
Countries
China
Contacts
Primary ContactZhenghao Cai, MD
Outcome results
None listed