Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, Induction chemotherapy, Concurrent chemoradiotherapy, Gemcitabine, Docetaxel
Brief summary
The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel，cisplatin regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by concurrent chemoradiotherapy.
Detailed description
Nasopharyngeal carcinoma (NPC) prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) and induction chemotherapy (IC) followed by CCRT plus AC as standard treatment for NPC. However, it was unclear whether patients with NPC could benefit from IC. Recently, many new drugs including docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The investigators designed the present study with induction chemotherapy follow by CCRT for locoregionally advanced NPC, comparing induction chemotherapy regime of gemcitabine plus cisplatin (GP) and docetaxel, cisplatin, and fluorouracil (TPF).
Interventions
DRUGA combination of Gemcitabine and cisplatin
The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
DRUGA combination of Docetaxel, cisplatin and 5-Fluorouracil
The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
Sponsors
Cancer Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). 2. 18 years to 70 years; 3. Tumor staged as T3-4N1/N2-3M0 (according to the 7th AJCC edition), 4. Performance status: Karnofsky scale (KPS) \> 70 (Appendix I ). 5. Adequate marrow: leucocyte count \> 4×109/L, neutrophil count \> 2×109/L, hemoglobin \> 90g/L and platelet count \> 100×109/L. 6. 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. 7. Adequate renal function: creatinine clearance \> 60 ml/min. 8. Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion criteria
1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Age \> 70 or \< 18. 3. Treatment with palliative intent. 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 6. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). 7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 8. 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 (FFS) | One year | From the date of registration to the date of either locally, regionally or distant failure or last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | One year | Survival from the date of registration to the date of death or last follow-up |
| Loco-regional failure-free survival (LFFS) | One year | Survival from the date of registration to the date of either locally, regional recurrence or last follow-up |
| Distant metastasis failure-free survival (DMFS) | One year | Survival from the date of registration to the date of either distant metastasis or last follow-up |
| Acute induction chemotherapy toxicity | Two months | The side effects will be evaluated according to NCI-CTC AE V 3.0. |
Contacts
Primary Contactxiaodong Zhu, Doctor
Backup ContactSong Qu, Doctor
Outcome results
None listed