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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• A biopsy proven histological diagnosis of rectal adenocarcinoma;

• An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;

• No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;

• MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;

• Age between 18-75 years;

• ECOG (Eastern US Cooperative Oncology Group) score: 0-1;

• 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;

• Willing to participate and informed consent signed;

Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Zhenghao Cai, MD
c3z2h1@alumni.sjtu.edu.cn
+862164458887
Time Frame
Start Date: 2021-10-20
Estimated Completion Date: 2025-06
Participants
Target number of participants: 51
Related Therapeutic Areas
Sponsors
Leads: Shanghai Minimally Invasive Surgery Center

This content was sourced from clinicaltrials.gov

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