Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients

Phase 2

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Aspirin

• Registration Number: NCT03290820
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26
• Study Start: 2018-01-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controlled Group	Radiotherapy	The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy.
Controlled Group	Concurrent chemotherapy	The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy.
Experimental Group	Radiotherapy	The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin.
Experimental Group	Concurrent chemotherapy	The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin.
Experimental Group	Aspirin	The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China