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

NCT03391843 · tracked via the Priya Life Science China tracker

Sponsor

RenJi Hospital

Phase

Phase 2

Started

2017-12-01

Last updated

2018-01-05

Condition(s) studied

Rectal Cancer Stage III

Investigational drug(s) / intervention(s)

FOLFOXIRI+Cetuximab regimenAll Folfoxiri trials (9) →All Cetuximab trials (161) →

FOLFOXIRI+Cetuximab regimen: 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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 18 to 75 years at diagnosis 2. Diagnosis of rectal adenocarcinoma 3. ECOG status: 0～1 4. Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2) 5. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: 1),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; Exclusion Criteria: 1. Patient had received pelvic radiotherapy; 2. Patient had received systemic chemotherapy 3. Pregnant and Nursing women 4. Had metastatic disease 5. Uncontrolled co-morbid illnesses or other concurrent disease 6. Patient had second malignant disease within 5 years 7. Patients refused to signed informed consent.

Primary outcome measure(s)

Pelvic complete resection rate — Up to 10 weeks
Pathologic confirmation

Trial sites (1)

Facility	City	Region	Status
Department of Radiation Oncology,Renji Hospital affiliated to Medical School, Shanghai Jiaotong University	Shanghai	S

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03391843 on ClinicalTrials.gov ↗ ← All trials in China