Nasopharyngeal Carcinoma by AJCC V8 Stage
Conditions
Keywords
Nimotuzumab, Nasopharyngeal Carcinoma, Induction Chemotherapy, Chemoradiation, Adjuvant Therapy
Brief summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
Interventions
DRUGNimotuzumab
Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .
DRUGGemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
DRUGCisplatin
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
RADIATIONIntensity-modulated radiotherapy
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Sponsors
People's Hospital of Baise
Second Affiliated Hospital of Guangzhou Medical University
People's Hospital of Guangxi Zhuang Autonomous Region
Guilin Medical University, China
LiuZhou People's Hospital
The First People's Hospital of Qinzhou
Wuzhou Red Cross Hospital
Youjiang Medical College for Nationalities
Fourth Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 to 70. 2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria). 3. Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\]. 4. ECOG performance score: 0 to 1. 5. Primary lesions can measurable. 6. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. 7. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula). 8. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
Exclusion criteria
1. Primary lesions or lymph node have been operated (except of operation for biopsy). 2. Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy. 3. Other malignant tumor. 4. Participation in other interventional clinical trials within 1 month. 5. History of Serious lung or heart disease. 6. Pregnant or breast-feeding women and women who refused to take contraceptive method. 7. Drug abuse or alcohol addiction. 8. History of serious allergic or allergy. 9. Refused or can't signed informed consent form. 10. Other patients who are considered ineligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | 5 years | Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival(DFS) | 5 years | DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier. |
| Locoregional failure-free survival(LRRFS) | 5 years | LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier. |
| Tumor control probability (TCP) | 5 years | Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. |
| Incidence rate of investigator-reported adverse events (AEs) | 5 years | Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 and radiation therapy oncology group (RTOG) toxicity criteria. |
| Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) | 5 years | Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment. |
| Distant Metastasis-free survival(DMFS) | 5 years | DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier. |
Countries
China
Contacts
Primary ContactYing Lu, MD
Outcome results
None listed