Status:
UNKNOWN
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 m...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01854203
Start Date
July 1 2013
End Date
December 1 2016
Last Update
July 30 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center,Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
2
State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
Guangzhou, China, 510060