Neoadjuvant treatment for locally advanced rectal cancer using cetuximab and chemotherapy with radiotherapy

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

This study is testing if a combination of a targeted drug called cetuximab with chemotherapy and radiation can help people with locally advanced rectal cancer do better before surgery.

Quick facts

• Study type: Observational
• Enrollment: 51 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Minimally Invasive Surgery Center (other)
• Drugs / interventions: chemotherapy, cetuximab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04923620 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of combining neoadjuvant cetuximab with chemotherapy (mFOLFOX6) and short-course radiotherapy for patients with RAS wild-type locally advanced rectal cancer. The approach aims to improve treatment outcomes by targeting specific genetic profiles and utilizing a multimodal treatment strategy. Participants will undergo a regimen that includes cetuximab, chemotherapy, and radiotherapy before any surgical intervention. The study is observational, focusing on real-world effectiveness and safety data.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with biopsy-proven rectal adenocarcinoma and specific genetic profiles (KRAS, NRAS, PI3KCA, and BRAF wild type).

Not a fit: Patients with mutations in KRAS, NRAS, or BRAF, or those who have previously undergone treatment for colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the outcomes for patients with locally advanced rectal cancer by enhancing tumor response prior to surgery.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using targeted therapies combined with radiotherapy for colorectal cancers.

Eligibility criteria

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;

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Zhenghao Cai, MD

Conditions: Neoadjuvant Treatment, Rectal Cancer, Cetuximab, Radiotherapy