Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

NCT ID: NCT04923620

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2025-06-30

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

Conditions

Neoadjuvant Treatment; Rectal Cancer; Cetuximab; Radiotherapy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

cetuximab+mFOLFOX6

cetuximab 500mg/m2 d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles

Intervention Type: DRUG

short-course radiotherapy

25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6

Intervention Type: RADIATION

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role: lead

Responsible Party

Cai Zhenghao

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenghao Cai, MD

Role: CONTACT

c3z2h1@alumni.sjtu.edu.cn

+862164458887

Facility Contacts

Zhenghao Cai

Role: primary

c3z2h1@alumni.sjtu.edu.cn

+862164458887

Other Identifiers

MISC-Cet-FOLFOX-SCRT

Identifier Type: -

Identifier Source: org_study_id