Nasopharyngeal CarcinomaPhase 3NCT04437329
Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
A Phase 3 study testing Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil and Nedaplatin in people with Nasopharyngeal Carcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil and Nedaplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095
Jinquan Liu, M.D, 0086-137-1086-6485, 609149209@qq.com
Bin Qi, M.D, 0086-135-8058-0985, qibin020@126.com
About this study
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
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Read the 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).
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil, Nedaplatin, Cisplatin, Intensity modulated-radiotherapy
- Keywords
- induction chemotherapy, nedaplatin, cisplatin, concurrent chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, nedaplatin, fluorouracilDrug
Also called DNF
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, cisplatin, fluorouracilDrug
Also called DPF
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.
NedaplatinDrug
Also called NDP
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
CisplatinDrug
Also called DDP
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapyRadiation
Also called IMRT
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.
| Study group | Role | What they receive |
|---|---|---|
| DNF-N | Experimental | 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 Receives: Drug: Docetaxel, nedaplatin, fluorouracil; Drug: Nedaplatin; Radiation: Intensity modulated-radiotherapy |
| DPF-P | Active comparator | 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 Receives: Drug: Docetaxel, cisplatin, fluorouracil; Drug: Cisplatin; Radiation: Intensity modulated-radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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)
Measured: 12 weeks after the interventions
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)
Measured: 12 weeks after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Aug 2020
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Quan Liu, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Investigators
- Jinquan Liu, M.D, Study director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437329
- Sponsor's protocol ID
- NPC-NDP
- Status last verified
- May 2022
- First submitted
- 3 Jun 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04437329
- Acronym / sponsor ID
- NPC-NDP
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- induction chemotherapy, nedaplatin, cisplatin, concurrent chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNF-N | Experimental | Drug: Docetaxel, nedaplatin, fluorouracil, Drug: Nedaplatin, Radiation: Intensity modulated-radiotherapy1. 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 |
| DPF-P | Active comparator | Drug: Docetaxel, cisplatin, fluorouracil, Drug: Cisplatin, Radiation: Intensity modulated-radiotherapy1. 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel, nedaplatin, fluorouracilAlso: DNFInduction 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. | Drug | DNF-N |
| Docetaxel, cisplatin, fluorouracilAlso: DPFInduction 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. | Drug | DPF-P |
| NedaplatinAlso: NDPConcurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy. | Drug | DNF-N |
| CisplatinAlso: DDPConcurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy. | Drug | DPF-P |
| Intensity modulated-radiotherapyAlso: IMRTIntensity 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. | Radiation | DNF-N, DPF-P |
Primary outcome
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.
6 secondary outcomes
Overall Survival(OS)
Time frame: 3 years
Locoregional Relapse-Free Survival(LRRFS)
Time frame: 3 years
Distant metastasis-Free Survival(DMFS)
Time frame: 3 years
Quality of life (QoL)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 12 weeks after the interventions
Disease Control Rate (DCR)
Time frame: 12 weeks after the interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinquan Liu, M.D study director
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil and Nedaplatin in people with Nasopharyngeal Carcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinquan Liu, M.D (0086-137-1086-6485, 609149209@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.