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NCT Number: NCT04437329

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Other names: DNF

Docetaxel, cisplatin, fluorouracil

Drug

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.

Other names: DPF

Nedaplatin

Drug

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

Other names: NDP

Cisplatin

Drug

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

Other names: DDP

Intensity modulated-radiotherapy

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.

Other names: IMRT

Primary outcomes

  1. Progress-Free Survival (PFS)

    Time frame: 3 years

    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.

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: 3 years

    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.

  2. Locoregional Relapse-Free Survival(LRRFS)

    Time frame: 3 years

    Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.

  3. Distant metastasis-Free Survival(DMFS)

    Time frame: 3 years

    Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.

  4. Quality of life (QoL)

    Time frame: 3 years

    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.

  5. Objective Response Rate (ORR)

    Time frame: 12 weeks after the interventions

    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)

  6. Disease Control Rate (DCR)

    Time frame: 12 weeks after the interventions

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Qi, M.D

CONTACT

[email protected]

0086-135-8058-0985

Jinquan Liu, M.D

CONTACT

[email protected]

0086-137-1086-6485

Sponsors and collaborators

Lead sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Jun 18, 2020
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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