Brief Title
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
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Overall survival
Secondary Outcome
Difference in the complete response rates between the two treatment arms
Condition
Nasopharyngeal Carcinoma
Intervention
Inductive chemotherapy + concurrent cisplatin and IMRT
Study Arms / Comparison Groups
IInductive chemotherapy + concurrent cisplatin and IMRT
Description: 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 (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
300
Start Date
July 2013
Completion Date
December 2016
Primary Completion Date
December 2016
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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
yong Su, M.D., +86+13829745245, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01854203
Organization ID
ChiECRCT-2013003
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
yong Su, M.D., Study Director, Sun Yat-sen University
Verification Date
July 2013