Brief Title
The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
Official Title
A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy With Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Brief Summary
The purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).
Detailed Description
Patients with non-keratinizing NPC T1-4N2-3或T3-4N0-1M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy or CCRT alone. Patients in experimental group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before intensity-modulated radiotherapy (IMRT). Patients in control group receive IMRT concurrently with weekly cisplatin 40 mg/m² up to 7cycles. IMRT is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. Our primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Failure-free survival
Secondary Outcome
Overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
Gemcitabine
Study Arms / Comparison Groups
Experimental
Description: Induction chemotherapy+IMRT gemcitabine and cisplatin regimen Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT).
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
236
Start Date
June 2015
Completion Date
June 2021
Primary Completion Date
June 2021
Eligibility Criteria
Inclusion Criteria: - Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including WHO II or III). - Tumor staged as T1-4N2-3或T3-4N0-1M0 (according to the 7th AJCC edition). - Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. - Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. - Adequate liver function: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤1.5×ULN. - Adequate renal function: creatinine clearance ≥ 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 or basaloid squamous cell carcinoma. - Treatment with palliative intent. - Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. - Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). - History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). - Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. - 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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Pei-Yu Huang, M. D., Ph.D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02460887
Organization ID
Sun Yat-sen University HPY
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Pei-Yu Huang, M. D., Ph.D., Principal Investigator, Sun Yat-sen University
Verification Date
October 2020