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Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients

NCT ID: NCT03290820

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Nasopharyngeal Carcinoma

Keywords

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nasopharyngeal carcinoma N2-3 disease distant metastasis aspirin survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Controlled Group

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

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

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

Concurrent chemotherapy

Intervention Type DRUG

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

Experimental Group

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

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

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

Concurrent chemotherapy

Intervention Type DRUG

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

Aspirin

Intervention Type DRUG

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

Interventions

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Radiotherapy

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

Intervention Type RADIATION

Concurrent chemotherapy

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

Intervention Type DRUG

Aspirin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yun-fei Xia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-fei Xia, M.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yun-fei Xia, M.D

Role: CONTACT

Phone: 86-13602805461

Email: [email protected]

Hui Chang, M.D

Role: CONTACT

Phone: 86-020-87343374

Email: [email protected]

Facility Contacts

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Hui Chang, M.D

Role: primary

Chen Chen, M.D

Role: backup

Other Identifiers

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2017-FXY-067

Identifier Type: -

Identifier Source: org_study_id