Nasopharyngeal Carcinoma Clinical Trial
Official title:
Aspirin Improve Survival of Patients With N2-3 Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized Controlled Trial
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.
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.
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