Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

Rectal Cancer Clinical Trial

Official title:

Efficacy and Safety of Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy for RAS Wild-type Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923620
• Other study ID #: MISC-Cet-FOLFOX-SCRT
• Status: Recruiting
• 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
• 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;

Related Conditions & MeSH terms

• Cetuximab
• Neoadjuvant Treatment
• Radiotherapy
• Rectal Cancer
• Rectal Neoplasms

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