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Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT03290820
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Yun-fei Xia, 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Radiotherapy Drug: Concurrent chemotherapy Drug: Aspirin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aspirin Improve Survival of Patients With N2-3 Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized Controlled Trial
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Controlled Group
The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy.
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.

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




Primary Outcome Measures :
  1. Distant-metastasis-free survival [ Time Frame: 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 :
  1. Overall survival [ Time Frame: 5 years after diagnosis ]
    The percentage of patients of a data set who survive after a defined period of time from pathologic diagnosis

  2. Aspirin-related toxicities [ Time Frame: 5 years after diagnosis ]
    Incidence of aspirin-related toxicities such as gastrointestinal bleeding and liver dysfunction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290820


Contacts
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Contact: Yun-fei Xia, M.D 86-13602805461 xiayf@sysucc.org.cn
Contact: Hui Chang, M.D 86-020-87343374 changhui@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hui Chang, M.D    86-020-87343374    changhui@sysucc.org.cn   
Contact: Chen Chen, M.D       chenchen@sysucc.org.cn   
Principal Investigator: Yun-fei Xia, M.D         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yun-fei Xia, M.D Sun Yat-sen University

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Responsible Party: Yun-fei Xia, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03290820     History of Changes
Other Study ID Numbers: 2017-FXY-067
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yun-fei Xia, Sun Yat-sen University:
nasopharyngeal carcinoma
N2-3 disease
distant metastasis
aspirin
survival

Additional relevant MeSH terms:
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Aspirin
Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics