Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

Recruiting

• Conditions: Neoadjuvant Treatment; Rectal Cancer; Cetuximab; Radiotherapy

• Registration Number: NCT04923620
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-06
• Study First Posted: 2021-06-11
• Study Start: 2021-10-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-08-31
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological response rate	two weeks after surgery	Tumor Regression Grade 0-1

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China