Carboplatin, Cisplatin, NPC
Conditions
Keywords
Nasopharyngeal Carcinoma, cisplatin, carboplatin
Brief summary
The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.
Detailed description
Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Interventions
DRUGDocetaxel,Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
DRUGDocetaxel,Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
RADIATIONCarboplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
RADIATIONCisplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). * Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) \> 70. * Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. * 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: 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. * Age ≥65 years or \<18 years. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation. * History of previous radiotherapy (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | 3-year | Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional failure-free survival | 3-year | Locoregional failure-free survival is calculated from randomisation to the first locoregional failure. |
| Distant failure-free survival | 3-year | Distant failure-free survival is calculated from randomisation to the first locoregional failure. |
| The initial response rates after treatments | A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy. | The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy. |
| Toxic effects | 3-year | Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0. |
| Overall survival | 3-year | Overall survival is calculated from randomization to death from any cause. |
Countries
China
Contacts
Primary ContactJian Guan, Ph.D.
Outcome results
None listed