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Nasopharyngeal CarcinomaPhase 3NCT01479504

A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

A Phase 3 study testing nedaplatin and docetaxel and cisplatin and docetaxel in people with Nasopharyngeal Carcinoma, run by Guangxi Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
nedaplatin and docetaxel and cisplatin and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteChina
Study dates
Nov 2011to Dec 2017
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
  • non-keratinizing or undifferentiated type
  • clinical stage III-IVb (UICC 7th edition)
  • age between 18-70
  • satisfactory performance status: Karnofsky scale (KPS) > 70.
  • hemoglobin > 100g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L
Show all 10Show fewer
  • serum creatinine level < 1.6 mg/dL or creatinine clearance ≥ 60 mL/min.
  • normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5ULN
  • patients must be informed of the investigational nature of this study and give written informed consent.
  • anticipated life span more than 6 month

Who cannot join

  • primary treatment with palliative intent
  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Evidence of distant metastases
  • pregnancy or lactation
  • history of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
  • prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
  • any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Trial locations and contacts

1 site in 1 country.

Wang R Sheng, M.D. contact

86(0771)3276223

wrsgx@yahoo.com.cn

Wu Fang, M.D. contact

86(0771)3276313

96160f@163.com

China1 site, 1 recruiting

  • Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Wang R Sheng, M.D., 8613807806008, wrsgx@yahoo.com.cn

    Wu Fang, M.D., 8613978880156, 96160f@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.

Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Read the detailed description

Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy（IMRT）group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Being tested
nedaplatin and docetaxel, cisplatin and docetaxel
Keywords
Nasopharyngeal Carcinoma, neoadjuvant chemotherapy, concurrent chemoradiotherapy, Nedaplatin
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nedaplatin and docetaxelDrug

    Also called TN

    neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy

    concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy

  • cisplatin and docetaxelDrug

    Also called TP

    neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy

    concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy

  • nedaplatin and docetaxelDrug

    Also called TN

    neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy

    concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy

  • cisplatin and docetaxelDrug

    Also called TP

    neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy

    concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy

Study groups in NCT01479504
Study groupRoleWhat they receive
1A(nedaplatin and IMRT)Experimentalneoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
Receives: Drug: nedaplatin and docetaxel
1B(cisplatin and IMRT)Active comparatorneoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
Receives: Drug: cisplatin and docetaxel
2A(nedaplatin and CRT)Experimentalneoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
Receives: Drug: nedaplatin and docetaxel
2B((cisplatin and CRT))Active comparatorneoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
Receives: Drug: cisplatin and docetaxel

What is being measured

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

  1. complete response (CR) rate

    3 months after treatment

    Measured: 3 months

Secondary outcomes (3)

  1. Acute toxicities

    Acute toxicity will be measured by CTCAE3.0

    Measured: 2 years

  2. Overall Survival

    1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival

    Measured: 1,3,5 years

  3. cost-effectiveness ratio

    Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).

    Measured: 3 months

Timeline

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

  1. First posted24 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2012 (estimated)
  4. Study completionDec 2017 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479504
Sponsor's protocol ID
GuangxiMU
Status last verified
Oct 2011
First submitted
16 Nov 2011
Last updated
28 Nov 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nedaplatin and docetaxel and cisplatin and docetaxel in people with Nasopharyngeal Carcinoma, run by Guangxi 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 10 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: status not confirmed, as of the sponsor's last update on 28 Nov 2011. 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?

Results are not available in the source record.

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

Contact Wang R Sheng, M.D. (86(0771)3276223, wrsgx@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response (CR) rate (time frame: 3 months). 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 NCT01479504.

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 28 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.

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