Clinical trial NCT01854203: Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
Official title: Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Cisplatin
neoadjuvant chemotherapy
intensity-modulated radiation therapy
concurrent chemoradiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Failure-free survival
timeFrame: 3-year
measure: Locoregional failure-free survival
timeFrame: 3-year
measure: Distant failure-free survival
timeFrame: 3-year
Secondary outcomes:
measure: Difference in the complete response rates between the two treatment arms
timeFrame: 12 weeks after the completion of therapy
Other outcomes:
measure: Rates of toxicity
timeFrame: 3-years
Locations:
city: Guangzhou
country: China
facility: Cancer Center,Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
Study officials:
affiliation: Sun Yat-sen University
name: yong Su, M.D.
role: STUDY_DIRECTOR
affiliation: Sun Yat-sen University
name: Janjun Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Lizhi Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: