Nasopharyngeal CarcinomaPhase 2NCT03290820
Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients
A Phase 2 study testing Radiotherapy, Concurrent chemotherapy and Aspirin in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Radiotherapy, Concurrent chemotherapy and Aspirin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic dianosis of nasopharyngeal carcinoma
- Stage of T1-4N2-3M0 (UICC/AJCC classification ver. 7)
- 18-70 years old
- Karnofsky performance score > 70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hui Chang, M.D, 86-020-87343374, changhui@sysucc.org.cn
Chen Chen, M.D, chenchen@sysucc.org.cn
About this study
Official title: Aspirin Improve Survival of Patients With N2-3 Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Radiotherapy, Concurrent chemotherapy, Aspirin
- Keywords
- nasopharyngeal carcinoma, N2-3 disease, distant metastasis, aspirin, survival
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Technique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
Concurrent chemotherapyDrug
Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
AspirinDrug
Daily aspirin of 75mg, from the starting date of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Group | Active comparator | The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy. Receives: Radiation: Radiotherapy; Drug: Concurrent chemotherapy |
| Experimental Group | Experimental | The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin. Receives: Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years after diagnosis
Secondary outcomes (2)
Overall survival
The percentage of patients of a data set who survive after a defined period of time from pathologic diagnosis
Measured: 5 years after diagnosis
Aspirin-related toxicities
Incidence of aspirin-related toxicities such as gastrointestinal bleeding and liver dysfunction
Measured: 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, M.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290820
- Sponsor's protocol ID
- 2017-FXY-067
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Improve Survival of Patients With N2-3 Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03290820
- Acronym / sponsor ID
- 2017-FXY-067
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, N2-3 disease, distant metastasis, aspirin, survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Controlled Group | Active comparator | Radiation: Radiotherapy, Drug: Concurrent chemotherapyThe patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy. |
| Experimental Group | Experimental | Radiation: Radiotherapy, Drug: Concurrent chemotherapy, Drug: AspirinThe patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologic dianosis of nasopharyngeal carcinoma
- Stage of T1-4N2-3M0 (UICC/AJCC classification ver. 7)
- 18-70 years old
- Karnofsky performance score > 70
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyTechnique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy. | Radiation | Controlled Group, Experimental Group |
| Concurrent chemotherapyNedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles. | Drug | Controlled Group, Experimental Group |
| AspirinDaily aspirin of 75mg, from the starting date of radiotherapy. | Drug | Experimental Group |
Primary outcome
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
2 secondary outcomes
Overall survival
Time frame: 5 years after diagnosis
Aspirin-related toxicities
Time frame: 5 years after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-fei Xia, M.D principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Concurrent chemotherapy and Aspirin in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-fei Xia, M.D (86-13602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant-metastasis-free survival (time frame: 5 years after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.