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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

nedaplatin and docetaxel

cisplatin and docetaxel

nedaplatin and docetaxel

cisplatin and docetaxel

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, neoadjuvant chemotherapy, concurrent chemoradiotherapy, Nedaplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1A(nedaplatin and IMRT)

1B(cisplatin and IMRT)

2A(nedaplatin and CRT)

2B((cisplatin and CRT))

Arm Description

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)

Outcomes

Primary Outcome Measures

complete response (CR) rate

3 months after treatment

Secondary Outcome Measures

Acute toxicities

Acute toxicity will be measured by CTCAE3.0

Overall Survival

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

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).

Full Information

NCT ID

NCT01479504

First Posted

November 16, 2011

Last Updated

November 24, 2011

Sponsor

Guangxi Medical University

Collaborators

People's Hospital of Guangxi, 303rd Hospital of the People's Liberation Army, Nanning Second People's Hospital, Guangxi Traditional Chinese Medical University, Guilin Medical College, Guangxi Naxishan Hospital, Liuzhou Workers Hospital, LiuZhou People's Hospital, Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Cancer Hospital, Liuzhou Railway hospital, First People's Hospital of Yulin, The Red Cross hospital of YuLin, Guigang People's Hospital, Wuzhou Red Cross Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01479504

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangxi Medical University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, neoadjuvant chemotherapy, concurrent chemoradiotherapy, Nedaplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1A(nedaplatin and IMRT)

Arm Type

Experimental

Arm Description

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)

Arm Title

1B(cisplatin and IMRT)

Arm Type

Active Comparator

Arm Description

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)

Arm Title

2A(nedaplatin and CRT)

Arm Type

Experimental

Arm Description

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)

Arm Title

2B((cisplatin and CRT))

Arm Type

Active Comparator

Arm Description

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)

Intervention Type

Drug

Intervention Name(s)

nedaplatin and docetaxel

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin and docetaxel

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

nedaplatin and docetaxel

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin and docetaxel

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

complete response (CR) rate

Description

3 months after treatment

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Acute toxicities

Description

Acute toxicity will be measured by CTCAE3.0

Time Frame

2 years

Title

Overall Survival

Description

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

Time Frame

1,3,5 years

Title

cost-effectiveness ratio

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wang R Sheng, M.D.

Phone

86(0771)3276223

wrsgx@yahoo.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wu Fang, M.D.

Phone

86(0771)3276313

96160f@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang R. sheng, M.D.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wang R sheng, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wu Fang, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang R Sheng, M.D.

Phone

8613807806008

wrsgx@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Wu Fang, M.D.

Phone

8613978880156

96160f@163.com

First Name & Middle Initial & Last Name & Degree

Wang R Sheng, M.D.

First Name & Middle Initial & Last Name & Degree

Wu Fang, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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