- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391843
Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer
FOLFOXIRI Combined With Cetuximab as a Neoadjuvant Chemotherapy for EGFR Wild Type Locally Advanced Rectal Cancer:A Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
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+cetuximab and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of the multidisciplinary team (MDT),otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625 mg/m²,bid po,d1-5,qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m², bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.
FOLFOXIRI+Cetuximab Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h + Cetuximab 500 mg/m²,all on day 1 of each 2 weeks cycle for 4-6 cycles,
Other Names:
CPT11,CAMPTO Eloxatin Xelod Erbitux
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
S
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Shanghai, S, China, 2
- Department of Radiation Oncology,Renji Hospital affiliated to Medical School, Shanghai Jiaotong University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FOLFOXIRI+Cetuximab
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic complete resection rate
Time Frame: Up to 10 weeks
|
Pathologic confirmation
|
Up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of local control
Time Frame: 3 years
|
Imaging diagnosis
|
3 years
|
The rate of receive chemoradiation
Time Frame: Up to 10 weeks
|
Record document
|
Up to 10 weeks
|
Disease free survival (DFS)
Time Frame: Three years
|
Imaging diagnosis
|
Three years
|
Overall survival
Time Frame: Three years
|
Record document
|
Three years
|
The rate of clinical complete response after 4 cycles of FOLFOXIRI
Time Frame: Up to 10 weeks
|
Pathologic confirmation
|
Up to 10 weeks
|
The incidence of >=3 grade adverse events
Time Frame: Two years
|
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
|
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Oxaliplatin
- Cetuximab
Other Study ID Numbers
- 2018CRC R-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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