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

NCT01479504 | Unknown Phase 3 DMC

• 1 other identifier: GuangxiMU
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; neoadjuvant chemotherapy; concurrent chemoradiotherapy; Nedaplatin

Outcome Measures

Primary Outcomes (1)

• complete response (CR) rate

  3 months after treatment

  3 months

Secondary Outcomes (3)

• Acute toxicities

  2 years

• Overall Survival

  1,3,5 years

• cost-effectiveness ratio

  3 months

Study Arms (4)

1A(nedaplatin and IMRT)

EXPERIMENTAL

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

Drug: nedaplatin and docetaxel

1B(cisplatin and IMRT)

ACTIVE COMPARATOR

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

Drug: cisplatin and docetaxel

2A(nedaplatin and CRT)

EXPERIMENTAL

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

Drug: nedaplatin and docetaxel

2B((cisplatin and CRT))

ACTIVE COMPARATOR

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

Drug: cisplatin and docetaxel

Interventions

nedaplatin and docetaxel DRUG

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

Also known as: TN

1A(nedaplatin and IMRT)

cisplatin and docetaxel DRUG

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

Also known as: TP

1B(cisplatin and IMRT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nedaplatin; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wang R. sheng, M.D.

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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang R Sheng, M.D.

CONTACT

86(0771)3276223; wrsgx@yahoo.com.cn

Wu Fang, M.D.

CONTACT

86(0771)3276313; 96160f@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 24, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2017
• Last Updated: November 28, 2011

Record last verified: 2011-10

Locations

CN (1)