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Nasopharyngeal CarcinomaPhase 2NCT04834206

Nedaplatin in Treatment for Nasopharyngeal Carcinoma

A Phase 2 study testing Docetaxel, nedaplatin, fluorouracil, IMRT and Nedaplatin in people with Nasopharyngeal Carcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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, IMRT and Nedaplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
1 May 2021to 1 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510095

Other trials in China

About this study

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.

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.

Read the 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).

Being tested
Docetaxel, nedaplatin, fluorouracil, IMRT, Nedaplatin
Keywords
Induction chemotherapy, Nedaplatin, Concurrent chemoradiotherapy, Nasopharyngeal Carcinoma
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.

  • IMRTRadiation

    Also called RT

    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.

  • NedaplatinDrug

    Also called N

    Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

Study groups in NCT04834206
Study groupRoleWhat they receive
DNF-NOther1. 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; Radiation: IMRT; Drug: Nedaplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate (ORR)

    CR+PR

    Measured: at the end of radiotherapy(±1week）

Secondary outcomes (5)

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 years

  3. 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.

    Measured: 3 years

  4. 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.

    Measured: 3 years

  5. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 May 2021
  3. Primary completion29 Oct 2021
  4. Study completion1 May 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04834206
Sponsor's protocol ID
NPC-NDP-SGL arm
Status last verified
May 2022
First submitted
1 Apr 2021
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen FZ, Deng Y, Yin WJ, Wang MY, Yang F, Yang ZH, Zhou LP, Chen SD, Chen JL, Jiang XZ, Zhou AX, Ou YM, Liu JQ, Chen DP, Qi B. Induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin and radiotherapy in locoregionally advanced nasopharyngeal carcinoma: A single arm, open label, phase II clinical trial. Transl Oncol. 2026 Feb;64:102634. doi: 10.1016/j.tranon.2025.102634. Epub 2026 Jan 6.

    PubMed 41496409

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, nedaplatin, fluorouracil, IMRT 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 7 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: finished, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: at the end of radiotherapy(±1week）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04834206, which also lists 1 linked publication.

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.

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