A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT01479504 |
Recruitment Status
: Unknown
Verified October 2011 by Wang Rensheng, Guangxi Medical University.
Recruitment status was: Recruiting
First Posted
: November 24, 2011
Last Update Posted
: November 28, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Carcinoma | Drug: nedaplatin and docetaxel Drug: cisplatin and docetaxel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | November 2012 |
Estimated Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: 1A(nedaplatin and IMRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
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Drug: nedaplatin and docetaxel
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 Other Name: TN
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Active Comparator: 1B(cisplatin and IMRT)
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
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Drug: cisplatin and docetaxel
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 Other Name: TP
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Experimental: 2A(nedaplatin and CRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
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Drug: nedaplatin and docetaxel
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 Other Name: TN
|
Active Comparator: 2B((cisplatin and CRT))
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
|
Drug: cisplatin and docetaxel
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 Other Name: TP
|
- complete response (CR) rate [ Time Frame: 3 months ]3 months after treatment
- Acute toxicities [ Time Frame: 2 years ]Acute toxicity will be measured by CTCAE3.0
- Overall Survival [ Time Frame: 1,3,5 years ]1 years,3 years and 5 years overall survival,disease free survival,distant metastases free survival
- cost-effectiveness ratio [ Time Frame: 3 months ]Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479504
Contact: Wang R Sheng, M.D. | 86(0771)3276223 | wrsgx@yahoo.com.cn | |
Contact: Wu Fang, M.D. | 86(0771)3276313 | 96160f@163.com |
China, Guangxi | |
Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University | Recruiting |
Nanning, Guangxi, China, 530021 | |
Contact: Wang R Sheng, M.D. 8613807806008 wrsgx@yahoo.com.cn | |
Contact: Wu Fang, M.D. 8613978880156 96160f@163.com | |
Principal Investigator: Wang R Sheng, M.D. | |
Principal Investigator: Wu Fang, M.D. |
Study Chair: | Wang R. sheng, M.D. | Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University | |
Principal Investigator: | Wang R sheng, M.D. | Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University | |
Principal Investigator: | Wu Fang, M.D. | Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University |
Responsible Party: | Wang Rensheng, Director, Guangxi Medical University |
ClinicalTrials.gov Identifier: | NCT01479504 History of Changes |
Other Study ID Numbers: |
GuangxiMU |
First Posted: | November 24, 2011 Key Record Dates |
Last Update Posted: | November 28, 2011 |
Last Verified: | October 2011 |
Keywords provided by Wang Rensheng, Guangxi Medical University:
Nasopharyngeal Carcinoma neoadjuvant chemotherapy concurrent chemoradiotherapy Nedaplatin |
Additional relevant MeSH terms:
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases |
Stomatognathic Diseases Otorhinolaryngologic Diseases Docetaxel Nedaplatin Cisplatin Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |