Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients

NCT03290820 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2017-10-26

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

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.

DRUG

Aspirin

Daily aspirin of 75mg, from the starting date of radiotherapy.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-fei Xia, M.D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290820 on ClinicalTrials.gov