Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

Shanghai Minimally Invasive Surgery Center

Status: Enrolling

Conditions: Neoadjuvant Treatment; Radiotherapy; Cetuximab; Rectal Cancer

Treatments: Radiation: short-course radiotherapy; Drug: cetuximab+mFOLFOX6

Study type: Observational

Funder types: Other

Identifiers

NCT04923620

MISC-Cet-FOLFOX-SCRT

Details and patient eligibility

About

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

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;