Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
1 other identifier
interventional
352
1 country
1
Brief Summary
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2020
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
May 10, 2022
May 1, 2022
7.9 years
June 3, 2020
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress-Free Survival (PFS)
Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
3 years
Secondary Outcomes (6)
Overall Survival(OS)
3 years
Locoregional Relapse-Free Survival(LRRFS)
3 years
Distant metastasis-Free Survival(DMFS)
3 years
Quality of life (QoL)
3 years
Objective Response Rate (ORR)
12 weeks after the interventions
- +1 more secondary outcomes
Study Arms (2)
DNF-N
EXPERIMENTAL1. Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy: three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
DPF-P
ACTIVE COMPARATOR1. Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy: three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
Interventions
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Eligibility Criteria
You may qualify if:
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
- No evidence of distant metastasis (M0)
- Age between 18-65
- WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
- With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
- With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
- Satisfactory performance status: KARNOFSKY scale (KPS) \> 70
- Patients must give signed informed consent
You may not qualify if:
- Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)
- Age \>65 or \< 18 years
- Treatment with palliative intent
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
- History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
- History of previous radiotherapy
- Pregnancy or lactation
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jinquan Liu, M.D
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President of Affiliated Tumor Hospital of Guangzhou Medical University
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 18, 2020
Study Start
August 1, 2020
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share