Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer

NCT03391843 | Active Not Recruiting Phase 2

• 1 other identifier: 2018CRC R-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone for local advanced rectal cancer(LARC), but they did not increase the ratio of pathological complete response (pCR) which was associated with improvement of overall survival (OS). On the other hand,some clinical trials show that triple active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) combined with cetuximab for EGFR wild type metastatic colorectal cancer had more effective than double agents.Therefore,a hypothesis is the FOLFOXIRI+Cetuximab as the neoadjuvant chemotherapy regimen might improve the patient's ratio of pCR.

Conditions

Rectal Cancer Stage III

Keywords

Local Advanced Rectal Cancer; Neoadjuvant Chemotherapy; FOLFOXIRI; Cetuximab; EGFR wild type

Outcome Measures

Primary Outcomes (1)

• Pelvic complete resection rate

  Pathologic confirmation

  Up to 10 weeks

Secondary Outcomes (6)

• The rate of local control

  3 years

• Disease free survival (DFS)

  Three years

• Overall survival

  Three years

• The rate of receive chemoradiation

  Up to 10 weeks

• The rate of clinical complete response after 4 cycles of FOLFOXIRI

  Up to 10 weeks

Study Arms (1)

FOLFOXIRI+Cetuximab

EXPERIMENTAL

FOLFOXIRI+Cetuximab regimen:Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h and cetuximab 500mg/m²,all on day 1 of each 2 weeks cycle for 4-6 cycles.

Drug: FOLFOXIRI+Cetuximab regimen

Interventions

FOLFOXIRI+Cetuximab regimen DRUG

FOLFOXIRI+Cetuximab Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h +Cetuximab 500mg/m²,all on day 1 of each 2 weeks cycle

Also known as: CPT 11,CAMPTO，Eloxatin，Xelod，Eloxatin,Erbitux

FOLFOXIRI+Cetuximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 to 75 years at diagnosis
• Diagnosis of rectal adenocarcinoma
• ECOG status: 0～1
• Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
• ),Leukocytes ≥ 3.0 x109/ L, 2),Absolute neutrophil count (ANC) ≥ 1.5 x109/ L 3),Platelet count ≥ 100 x109/ L, 4),Hemoglobin (Hb) ≥ 9g/ dL. 5),Total bilirubin ≤1.5 x the upper limit of normal (ULN). 6),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 x ULN. 7),Serum creatinine ≤ 1.5 x the ULN. 8),Signed informed consent;

You may not qualify if:

• Patient had received pelvic radiotherapy;
• Patient had received systemic chemotherapy
• Pregnant and Nursing women
• Had metastatic disease
• Uncontrolled co-morbid illnesses or other concurrent disease
• Patient had second malignant disease within 5 years
• Patients refused to signed informed consent.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of Radiation Oncology,Renji Hospital affiliated to Medical School, Shanghai Jiaotong University

Shanghai, S, 2, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ming Ye, Master

  Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Renji Hospital

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: December 1, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

CN (1)