Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer
Lead Sponsor:
RenJi Hospital
Conditions:
Rectal Cancer Stage III
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 com...
Detailed Description
This is a multicenter, phase II trial to assess the efficacy and safety of triplet regimen (FOLFOXIRI) combined with cetuximab for patients with EGFR wild type LARC. After 4 cycles of FOLFOXIRI+cetuxi...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03391843
Start Date
December 1 2017
End Date
December 31 2027
Last Update
January 5 2018
Active Locations (1)
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1
Department of Radiation Oncology,Renji Hospital affiliated to Medical School, Shanghai Jiaotong University
Shanghai, S, China, 2