Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

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

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

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Radiotherapy; Neoadjuvant Treatment; Cetuximab
• Intervention / Treatment: Drug: cetuximab+mFOLFOX6; Radiation: short-course radiotherapy

• Study Type: Observational
• Enrollment (Estimated): 51

Contacts and Locations

• Study Contact: Name: Zhenghao Cai, MD; Phone Number: +862164458887; Email: c3z2h1@alumni.sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200020
      • Recruiting
      • Ruijin Hospital
      • Contact: Zhenghao Cai; Phone Number: +862164458887; Email: c3z2h1@alumni.sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 75 years with locally advanced rectal cancer, regardless of gender, ethnicity and regional distribution, were involved in this study. Patients were required to be in good health and have sufficient organ function and bone marrow function.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response rate	Tumor Regression Grade 0-1	two weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Overall survival	Refers to the time from the start of treatment to death due to any cause.	2 years after enrollment
disease-free survival	Refers to the time from the start of treatment to recurrence.	2 years after enrollment

Collaborators and Investigators

• Sponsor: Shanghai Minimally Invasive Surgery Center

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: MISC-Cet-FOLFOX-SCRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No