Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03290820
• Other study ID #: 2017-FXY-067
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 13, 2017
• Last updated: October 25, 2017
• Start date: January 1, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Yun-fei Xia, M.D
• Phone: 86-13602805461
• Email: xiayf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• Radiotherapy
Technique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.

Drug:
• Concurrent chemotherapy
Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
• Aspirin
Daily aspirin of 75mg, from the starting date of radiotherapy.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distant-metastasis-free survival	The percentage of patients of a data set who survive without distant metastasis after a defined period of time from pathologic diagnosis	5 years after diagnosis
Secondary	Overall survival	The percentage of patients of a data set who survive after a defined period of time from pathologic diagnosis	5 years after diagnosis
Secondary	Aspirin-related toxicities	Incidence of aspirin-related toxicities such as gastrointestinal bleeding and liver dysfunction	5 years after diagnosis