Brief Title
Effect of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy in High Risk Nasopharyngeal Carcinoma
Official Title
Randomized Phase 3 Trial of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy Versus Concurrent Chemotherapy Alone in High Risk Nasopharyngeal Carcinoma Patients Treated With Intensity-modulated Radiotherapy
Brief Summary
The investigators aim to evaluate the survival benefit from triple combination of induction,
concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk
locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated
radiotherapy.
Detailed Description
All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68
to 70 Gy in 33 fractions to the primary tumor. Patients in the experimental arm receive
triple therapy of induction, concurrent and adjuvant chemotherapy. Induction chemotherapy
consists of docetaxel 75 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 2 cycles.
Concurrent chemotherapy in the experimental arm consists of cisplatin 25 mg/m², D1-3 every 3
weeks and Xeloda 2000mg/m², D1-14 for 3 cycles. Adjuvant chemotherapy consists of Xeloda
2500mg/m², D1-14 for 2 cycles. Concurrent chemotherapy in the control arm consists of
cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is failure-free
survival (FFS). Secondary end points include overall survival (OS), locoregional relapse-free
survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or
higher acute toxicities. 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
Cisplatin 1
Study Arms / Comparison Groups
IC plus CC plus IMRT plus AC
Description: Induction chemotherapy: TP -- Docetaxel 75mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 2 cycles; Concurrent chemotherapy: PX -- Cisplatin 25 mg/m2, D1-3 and Xeloda 2000mg/m2, D1-14, every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy; Adjuvant chemotherapy: Xeloda 2500mg/m2, D1-14, every 3 weeks for 2 cycles
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
534
Start Date
January 2016
Completion Date
January 2024
Primary Completion Date
January 2022
Eligibility Criteria
Inclusion Criteria:
- Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
- Tumor staged as T4N0-3M0 or T1-3N3M0 (the 2010 UICC/AJCC staging system).
- Pretreatment EBV DNA ≥ 4000 copies/mL.
- Karnofsky scale (KPS) ≥ 70.
- Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥
100×10E9/L.
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase
(AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline
phosphatase (ALP) ≤ 2.5×ULN.
- Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
- Patients must give written informed consent.
Exclusion Criteria:
- 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 radiotherapy (except for non-melanomatous skin cancers outside
intended radiotherapy volume).
- Prior radiotherapy, 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.
- Dihydropyrimidine dehydrogenase deficiency.
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Fang-Yun Xie, M.D., +86-020-87342618, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02621970
Organization ID
2015-FXY-098-Dept. of RT
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Sponsor
Fang-Yun Xie, M.D., Principal Investigator, Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China
Verification Date
December 2015