Nasopharyngeal Carcinoma
Conditions
Keywords
nasopharyngeal carcinoma, N2-3 disease, distant metastasis, aspirin, survival
Brief summary
Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached 85.0% or more. However, even after chemoradiation, the 5-year distant-metastasis rate of patients with N2-3 NPC is still 36.7%. Aspirin is proven in lab and clinical studies to have the abilities of inhibiting the inflammation which could enhance metastasis of breast and colorectal cancers. And before this study, it was discovered that regular aspirin intake might be associated with distant-metastasis-free survival (MFS) and OS independently. So this Phase 2 trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC.
Detailed description
Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached 85.0% or more. However, the prognosis of the patients with late N (N2-3) diseases remains poor. Even after chemoradiation, the 5-year distant-metastasis rate of these patients is nearly 36.7%. Additionally, these patients occupies about 30.0% of the whole NPC population. To improve the prognosis of the patients with N2-3 NPC, there is a need to explore a new, practical and effective method to eliminate the distant metastasis. Aspirin is proven in lab and clinical studies to have the abilities of inhibiting the inflammation which could enhance metastasis of many malignant tumors, such as breast and colorectal cancers. And before this study, patients with N2-3 nonmetastatic NPC between 2008 and 2011 were retrospectively analyzed, to discovered that regular aspirin intake might be associated with distant-metastasis-free survival (MFS) and OS independently. So this Phase 2 randomized controlled trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC. This study aim to enroll patients with T1-4N2-3M0 NPC. All the patients will be treated with IMRT and concurrent chemotherapy of the PF (Nedaplatin + 5-flurouracil) regimen. After randomization, patients in the Experimental Group will also receive daily aspirin of 75mg. The 5-year MFS is the primary endpoint. And the 5-year OS and aspirin-related toxicities are the secondary endponits.
Interventions
RADIATIONRadiotherapy
Technique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
DRUGConcurrent chemotherapy
Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
DRUGAspirin
Daily aspirin of 75mg, from the starting date of radiotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patients eligible are divided randomly. All the patients will receive concurrent chemoradiotherapy. The cases in the Experimental Group will receive daily aspirin of 75mg.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathologic dianosis of nasopharyngeal carcinoma * Stage of T1-4N2-3M0 (UICC/AJCC classification ver. 7) * 18-70 years old * Karnofsky performance score \> 70
Exclusion criteria
* Distant metastasis before or during radiotherapy * Severe dysfunctions of liver, kidney, lung, heart of bone marrow which are not fit for radiotherapy * Prior malignancies * Prior history of radiotherapy, chemotherapy or monoclonal antibody therapy * Participation of other drug trials within 3 months * Regular use of aspirin before dianosis * Contraindication or allergy of aspirin * Patients who are considered by the researchers not suitable to participate this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant-metastasis-free survival | 5 years after diagnosis | The percentage of patients of a data set who survive without distant metastasis after a defined period of time from pathologic diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years after diagnosis | The percentage of patients of a data set who survive after a defined period of time from pathologic diagnosis |
| Aspirin-related toxicities | 5 years after diagnosis | Incidence of aspirin-related toxicities such as gastrointestinal bleeding and liver dysfunction |
Countries
China
Contacts
Primary ContactYun-fei Xia, M.D
Backup ContactHui Chang, M.D
Outcome results
None listed