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Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel, nedaplatin, fluorouracil
Docetaxel, cisplatin, fluorouracil
Nedaplatin
Cisplatin
Intensity modulated-radiotherapy
Sponsored by
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring induction chemotherapy, nedaplatin, cisplatin, concurrent chemoradiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DNF-N

DPF-P

Arm Description

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 Concurrent chemoradiotherapy: three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy Radiotherapy: radical intense modulated radiation therapy

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 Concurrent chemoradiotherapy: three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy Radiotherapy: radical intense modulated radiation therapy

Outcomes

Primary Outcome Measures

Progress-Free Survival (PFS)
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 Outcome Measures

Overall Survival(OS)
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.
Locoregional Relapse-Free Survival(LRRFS)
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(DMFS)
Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.
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.
Objective Response Rate (ORR)
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)
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)

Full Information

First Posted
June 3, 2020
Last Updated
May 6, 2022
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04437329
Brief Title
Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
induction chemotherapy, nedaplatin, cisplatin, concurrent chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DNF-N
Arm Type
Experimental
Arm Description
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 Concurrent chemoradiotherapy: three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy Radiotherapy: radical intense modulated radiation therapy
Arm Title
DPF-P
Arm Type
Active Comparator
Arm Description
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 Concurrent chemoradiotherapy: three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy Radiotherapy: radical intense modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel, nedaplatin, fluorouracil
Other Intervention Name(s)
DNF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel, cisplatin, fluorouracil
Other Intervention Name(s)
DPF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Other Intervention Name(s)
NDP
Intervention Description
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Intensity modulated-radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progress-Free Survival (PFS)
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Description
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.
Time Frame
3 years
Title
Locoregional Relapse-Free Survival(LRRFS)
Description
Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.
Time Frame
3 years
Title
Distant metastasis-Free Survival(DMFS)
Description
Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.
Time Frame
3 years
Title
Quality of life (QoL)
Description
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.
Time Frame
3 years
Title
Objective Response Rate (ORR)
Description
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)
Time Frame
12 weeks after the interventions
Title
Disease Control Rate (DCR)
Description
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)
Time Frame
12 weeks after the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinquan Liu, M.D
Phone
0086-137-1086-6485
Email
609149209@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Qi, M.D
Phone
0086-135-8058-0985
Email
qibin020@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinquan Liu, M.D
Organizational Affiliation
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinquan Liu, M.D
Phone
0086-137-1086-6485
Email
609149209@qq.com
First Name & Middle Initial & Last Name & Degree
Bin Qi, M.D
Phone
0086-135-8058-0985
Email
qibin020@126.com
First Name & Middle Initial & Last Name & Degree
Jinquan Liu, M.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

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