Nedaplatin in Treatment for Nasopharyngeal Carcinoma

NCT04834206 | Completed Phase 2 DMC

• 1 other identifier: NPC-NDP-SGL arm
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Induction chemotherapy; Nedaplatin; Concurrent chemoradiotherapy; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  CR+PR

  at the end of radiotherapy(±1week）

Secondary Outcomes (5)

• Overall Survival(OS)

  3 years

• Progress-Free Survival (PFS)

  3 years

• Locoregional Relapse-Free Survival(LRRFS)

  3 years

• Distant metastasis-Free Survival(DMFS)

  3 years

• Quality of life (QoL)

  3 years

Study Arms (1)

DNF-N

OTHER

1. 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

Drug: Docetaxel, nedaplatin, fluorouracil; Radiation: IMRT; Drug: Nedaplatin

Interventions

Docetaxel, nedaplatin, fluorouracil DRUG

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.

Also known as: DNF

DNF-N

IMRT RADIATION

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.

Also known as: RT

DNF-N

Nedaplatin DRUG

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

Also known as: N

DNF-N

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University

Guangzhou, Guangdong, 510095, China

Location

Related Publications (1)

• Chen FZ, Deng Y, Yin WJ, Wang MY, Yang F, Yang ZH, Zhou LP, Chen SD, Chen JL, Jiang XZ, Zhou AX, Ou YM, Liu JQ, Chen DP, Qi B. Induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin and radiotherapy in locoregionally advanced nasopharyngeal carcinoma: A single arm, open label, phase II clinical trial. Transl Oncol. 2026 Jan 6;64:102634. doi: 10.1016/j.tranon.2025.102634. Online ahead of print.

  PMID: 41496409 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Docetaxel; nedaplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jinquan Liu, M.D

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: October 29, 2021
• Study Completion: May 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)