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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04923620
Other study ID # MISC-Cet-FOLFOX-SCRT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 20, 2021
Est. completion date June 2025

Study information

Verified date February 2024
Source Shanghai Minimally Invasive Surgery Center
Contact Zhenghao Cai, MD
Phone +862164458887
Email c3z2h1@alumni.sjtu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date June 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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;

Study Design


Intervention

Drug:
cetuximab+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
Radiation:
short-course radiotherapy
25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6

Locations

Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathological response rate Tumor Regression Grade 0-1 two weeks after surgery
Secondary Pathological complete response rate Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0) two weeks after surgery
Secondary 2-year local control rate 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. 2 years after enrollment
Secondary 2-year metastasis-free rate 2-year distant metastasis free rate Refers to the probability of no distant metastasis within 2 years 2 years after enrollment
Secondary Overall survival Refers to the time from the start of treatment to death due to any cause. 2 years after enrollment
Secondary disease-free survival Refers to the time from the start of treatment to recurrence. 2 years after enrollment
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