- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04834206
Nedaplatin in Treatment for Nasopharyngeal Carcinoma
May 6, 2022 updated by: Jin-Quan Liu, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510095
- Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University
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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:
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: DNF-N
|
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:
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:
Concurrent chemotherapy.
nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate (ORR)
Time Frame: at the end of radiotherapy(±1week)
|
CR+PR
|
at the end of radiotherapy(±1week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival(OS)
Time Frame: 3 years
|
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.
|
3 years
|
Progress-Free Survival (PFS)
Time Frame: 3 years
|
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.
|
3 years
|
Locoregional Relapse-Free Survival(LRRFS)
Time Frame: 3 years
|
Relapse-free survival was defined as the time from beginning of treatment to local or regional relapse, or death from any cause.
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3 years
|
Distant metastasis-Free Survival(DMFS)
Time Frame: 3 years
|
Distant metastasis-free survival was defined as the time from beginning of treatment to distant metastasis, or death from any cause.
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3 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 1, 2021
Primary Completion (Actual)
October 29, 2021
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
April 1, 2021
First Submitted That Met QC Criteria
April 3, 2021
First Posted (Actual)
April 8, 2021
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Fluorouracil
- Nedaplatin
Other Study ID Numbers
- NPC-NDP-SGL arm
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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