Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC

Nasopharyngeal Carcinoma Clinical Trial

— NPC  

Official title:

Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01854203
• Other study ID #: ChiECRCT-2013003
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 10, 2013
• Last updated: July 28, 2013
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2013
• Source: Sun Yat-sen University
• Contact: Janjun Li, M.D.
• Phone: +86+13829745245
• Email: lijj[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.

Description:

The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).

• A Karnofsky performance status of at least 80;

• Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III:T1-2N2M0, T3N0-2M0 Stage IVa:T4N0-2M0 Stage IVb:Any T?N3.

• Adequate marrow: a WBC =3.5×109 l-1; a platelet count =100×109 l-1; and hemoglobin levels =100 g/l.

• 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 =ULN.

• Adequate renal function: a creatinine clearance rate of at least 60 mL/min.

• Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

• WHO Type keratinizing squamous cell carcinoma.

• Age >65 years or <18 years.

• Distant metastasis,

• Treatment with palliative intent.

• Pregnancy or lactation.

• a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.

• history of renal disease, unstable cardiac disease requiring treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Inductive chemotherapy + concurrent cisplatin and IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2,on day 1) repeated every week for 6 cycles during radiotherapy.
• Inductive chemotherapy + IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.

Locations

Country	Name	City	State
China	Cancer Center,Sun Yat-sen University	Guangzhou	Guangdong
China	State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of toxicity	Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.	3-years	Yes
Primary	Overall survival	Overall survival is calculated from randomization to death from any cause.	3-year	No
Primary	Failure-free survival	Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.	3-year	No
Primary	Locoregional failure-free survival	the latency to the first local failure	3-year	No
Primary	Distant failure-free survival	The latency to the first remote failure	3-year	No
Secondary	Difference in the complete response rates between the two treatment arms		12 weeks after the completion of therapy	No