Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04437329
• Other study ID #: NPC-NDP
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: June 30, 2029

Study information

• Verified date: May 2022
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: Jinquan Liu, M.D
• Phone: 0086-137-1086-6485
• Email: 609149209[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

Description:

This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III

2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system

3. No evidence of distant metastasis (M0)

4. Age between 18-65

5. WBC=4×10^9/ l, platelet = 100×10^9/ l and hemoglobin = 90g/l

6. With normal liver function test (TBIL?ALT?AST = 2.5×uln)

7. With normal renal function test (creatinine = 1.5×uln or ccr = 60ml/min)

8. Satisfactory performance status: KARNOFSKY scale (KPS) > 70

9. Patients must give signed informed consent

Exclusion Criteria:

1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)

2. Age >65 or < 18 years

3. Treatment with palliative intent

4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer

5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes

6. History of previous radiotherapy

7. Pregnancy or lactation

8. 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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Docetaxel, nedaplatin, fluorouracil
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.
• Docetaxel, cisplatin, fluorouracil
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.
• Nedaplatin
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
• Cisplatin
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

Radiation:
• Intensity modulated-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.

Locations

Country	Name	City	State
China	Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival(OS)	The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.	3 years
Secondary	Locoregional Relapse-Free Survival(LRRFS)	Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.	3 years
Secondary	Distant metastasis-Free Survival(DMFS)	Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.	3 years
Secondary	Quality of life (QoL)	Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H&N35). The EORTC QLQ-H&N35 scale employs a 4-point response format ("not at all" to "very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits.	3 years
Secondary	Objective Response Rate (ORR)	Objective Response Rate (ORR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)	12 weeks after the interventions
Secondary	Disease Control Rate (DCR)	Disease Control Rate (DCR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)	12 weeks after the interventions