Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

May 6, 2022 updated by: Jin-Quan Liu, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

352

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinquan Liu, M.D
  • Phone Number: 0086-137-1086-6485
  • Email: 609149209@qq.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • Recruiting
        • Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jinquan Liu, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DNF-N

  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
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
Drug: Nedaplatin
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Other Names:
  • NDP
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.
Other Names:
  • IMRT
Active Comparator: DPF-P

  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
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.
Other Names:
  • IMRT
Drug: 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.
Other Names:
  • DPF
Drug: Cisplatin
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Other Names:
  • DDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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.
3 years
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 years
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.
3 years
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)
12 weeks after the interventions
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)
12 weeks after the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Investigators

  • Study Director: Jinquan Liu, M.D, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

June 30, 2028

Study Completion (Anticipated)

June 30, 2029

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-NDP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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