Know Cancer

or
forgot password

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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete response (CR) rate

Outcome Description:

3 months after treatment

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Wang R. sheng, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

China: Ethics Committee

Study ID:

GuangxiMU

NCT ID:

NCT01479504

Start Date:

November 2011

Completion Date:

December 2017

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Carcinoma
  • neoadjuvant chemotherapy
  • concurrent chemoradiotherapy
  • Nedaplatin
  • Carcinoma
  • Nasopharyngeal Neoplasms

Name

Location