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Nedaplatin in Treatment for Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel, nedaplatin, fluorouracil
IMRT
Nedaplatin
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, Concurrent chemoradiotherapy, Nasopharyngeal Carcinoma

Eligibility Criteria

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

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:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DNF-N

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

Outcomes

Primary Outcome Measures

objective response rate (ORR)
CR+PR

Secondary Outcome Measures

Overall Survival(OS)
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 (PFS)
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.
Locoregional Relapse-Free Survival(LRRFS)
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(DMFS)
Distant metastasis-free survival was defined as the time from beginning of treatment 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.

Full Information

First Posted
April 1, 2021
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
NCT04834206
Brief Title
Nedaplatin in Treatment for Nasopharyngeal Carcinoma
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

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 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.
Detailed Description
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).

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, Concurrent chemoradiotherapy, Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DNF-N
Arm Type
Other
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
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
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
RT
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.
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Other Intervention Name(s)
N
Intervention Description
Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Primary Outcome Measure Information:
Title
objective response rate (ORR)
Description
CR+PR
Time Frame
at the end of radiotherapy(±1week）
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Description
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.
Time Frame
3 years
Title
Progress-Free Survival (PFS)
Description
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.
Time Frame
3 years
Title
Locoregional Relapse-Free Survival(LRRFS)
Description
Relapse-free survival was defined as the time from beginning of treatment 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 beginning of treatment 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

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: 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.
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 Universityedical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Nedaplatin in Treatment for Nasopharyngeal Carcinoma

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