Nedaplatin in Treatment for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834206
• Other study ID #: NPC-NDP-SGL arm
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

Description:

This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 1, 2022
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Treatment with palliative intent

• The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)

• 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.

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.

Radiation:
• IMRT
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.

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

Locations

Country	Name	City	State
China	Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical 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	objective response rate (ORR)	CR+PR	at the end of radiotherapy(±1week)
Secondary	Overall Survival(OS)	The OS was defined as the duration from the date of beginning of treatment to the date of death from any cause or censored at the date of the last follow-up.	3 years
Secondary	Progress-Free Survival (PFS)	Progress-free survival is calculated from the date of beginning of treatment to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.	3 years
Secondary	Locoregional Relapse-Free Survival(LRRFS)	Relapse-free survival was defined as the time from beginning of treatment 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 beginning of treatment 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