Neoplasms

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Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Cisplatin

Nedaplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

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

1. 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

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, nedaplatin, 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.

Docetaxel, cisplatin, fluorouracil

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.

Intensity modulated-radiotherapy

Jinquan Liu, M.D

Bin Qi, M.D

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

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).

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

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

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.

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.

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

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

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.

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)

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)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

President of Affiliated Tumor Hospital of Guangzhou Medical University

IMRT

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

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.

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).

Nedaplatin in Treatment for Nasopharyngeal Carcinoma

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.

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.

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.

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

Distant metastasis-free survival was defined as the time from beginning of treatment to distant metastasis, or death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma	NCT04437329	Nasopharyngeal ...	Docetaxel, neda... Docetaxel, cisp... Nedaplatin Cisplatin Intensity modul...	18 Years - 65 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma	NCT04437329	Nasopharyngeal ...	Docetaxel, neda... Docetaxel, cisp... Nedaplatin Cisplatin Intensity modul...	18 Years - 65 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Nedaplatin in Treatment for Nasopharyngeal Carcinoma	NCT04834206	Nasopharyngeal ...	Docetaxel, neda... IMRT Nedaplatin	18 Years - 65 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Nedaplatin in Treatment for Nasopharyngeal Carcinoma	NCT04834206	Nasopharyngeal ...	Docetaxel, neda... IMRT Nedaplatin	18 Years - 65 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Spots Global Cancer Trial Database for docetaxel, nedaplatin, fluorouracil