Locally Advanced Nasopharyngeal Carcinoma
Conditions
Keywords
nasopharyngeal carcinoma, Induction chemotherapy, radiotherapy, chemoradiotherapy
Brief summary
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
Detailed description
In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
Interventions
DRUGDocetaxel
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
DRUGCisplatin
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
RADIATIONIMRT/TOMO
intensity modulated radiation therapy or tomotherapy
DRUGChemotherapy
2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
Sponsors
Zhejiang Provincial People's Hospital
The Central Hospital of Lishui City
Jinhua Central Hospital
First Affiliated Hospital of Wenzhou Medical University
Ningbo Medical Center Lihuili Eastern Hospital
People's Hospital of Quzhou
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed non-keratinizing carcinoma. 2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system) 3. No evidence of distant metastasis (M0) 4. Performance status: KPS\>70 5. With normal liver function test (ALT, AST \<1.5ULN) 6. Renal: creatinine clearance \>60ml/min 7. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L. 8. With controlled blood glucose for diabetes patients 9. Written informed consent 10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
Exclusion criteria
1. WHO type I squamous cell carcinoma or adenocarcinoma 2. Age \>65 or \<18 3. With a history of renal disease 4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) 5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) 6. Patient is pregnant or lactating 7. Peripheral neuropathy 8. Emotional disturbance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress Free Survival (PFS) | 3 years after the inception assignment | PFS means assignment to the date of any local or distant progress of the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3 years and 5 years after the inception of the assignment | The overall survival denote to assignment to date of death from any cause. |
| Adverse Events | Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years | Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up. |
Countries
China
Contacts
Primary ContactXiaozhong Chen
Outcome results
None listed