NCT03290820

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

6.8 years

First QC Date

September 13, 2017

Last Update Submit

October 25, 2017

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinomaN2-3 diseasedistant metastasisaspirinsurvival

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival

    5 years after diagnosis

  • Aspirin-related toxicities

    5 years after diagnosis

Study Arms (2)

Controlled Group

ACTIVE COMPARATOR

The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy.

Radiation: RadiotherapyDrug: Concurrent chemotherapy

Experimental Group

EXPERIMENTAL

The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin.

Radiation: RadiotherapyDrug: Concurrent chemotherapyDrug: Aspirin

Interventions

RadiotherapyRADIATION

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

Controlled GroupExperimental Group
Concurrent chemotherapyDRUG

Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.

Controlled GroupExperimental Group
AspirinDRUG

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

Experimental Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic dianosis of nasopharyngeal carcinoma
  • Stage of T1-4N2-3M0 (UICC/AJCC classification ver. 7)
  • years old
  • Karnofsky performance score \> 70

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

RadiotherapyAspirin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Yun-fei Xia, M.D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, M.D

CONTACT

86-13602805461xiayf@sysucc.org.cn

Hui Chang, M.D

CONTACT

86-020-87343374changhui@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 25, 2017

Study Start

January 1, 2018

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)