Clinical trial NCT03290820: Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients
Official title: Aspirin Improve Survival of Patients With N2-3 Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
N2-3 disease
distant metastasis
aspirin
survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distant-metastasis-free survival
timeFrame: 5 years after diagnosis
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years after diagnosis
measure: Aspirin-related toxicities
timeFrame: 5 years after diagnosis
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yun-fei Xia, M.D
role: PRINCIPAL_INVESTIGATOR
References: