- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108338
Prospective Comparisons of Clinical Trial and Real-world Outcomes in Nasopharyngeal Carcinoma
Prospective Comparisons of Survival Outcomes, Safety Profile, and Probability of Returning to Society Between Three Randomized Controlled Trials and Real-world Evidence in Nasopharyngeal Carcinoma.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with locoregionally advanced nasopharyngeal carcinoma (T3-4N1 and T1-4N2-3). There are two parts of the constitution of study population.
Part 1. 1,468 subjects from three phase 3 randomized controlled trials ((NCT00677118, NCT01245959, and NCT01872962) that were conducted by our research team and had been published.
Part 2. 3,980 subjects from the NPC-specific big-data, real-world database via a cancer registry in Southern China.
Description
Inclusion Criteria:
- Patients treated in our center from April 2009 to December 2016;
- All patients were pathologically diagnosed, non-metastatic nasopharyngeal carcinoma;
- Only included cases staged as T3-4N1 & T1-4N2-3 according to the 6th or 7th edition American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) system;
- For trial patients, treatment strategies only limited to concurrent chemoradiotherapy, induction chemotherapy combined with concurrent chemoradiotherapy, or concurrent chemoradiotherapy combined with adjuvant chemotherapy;
- For patients from real-world database, patients are permitted to receive additional targeted therapy to standard chemoradiotherapy, as far as it met clinical needs and was approved by physicians.
- The patient's basic information, prognosis related data, and follow-up data are complete.
Exclusion Criteria:
- The clinical stage of T3-4N0 was excluded;
- Cases from large real-world databases need to exclude patients who participate in clinical trials;
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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CCRT-randomized clinical trial
Trial patients receiving CCRT
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Study results from clinical trials usually have been found not work efficiently in clinical practice.
This outcome disparity may be caused by different pragmatic features of medical environment, also known as study setting such as trial setting and real-world setting, in which biases inherent to clinical trial design restrict its applicability even though all confounding factors are avoided.
Other Names:
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CCRT-real-world database
Patients receiving CCRT from real-world database
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IC+CCRT-randomized clinical trial
Trial patients receiving IC+CCRT
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Study results from clinical trials usually have been found not work efficiently in clinical practice.
This outcome disparity may be caused by different pragmatic features of medical environment, also known as study setting such as trial setting and real-world setting, in which biases inherent to clinical trial design restrict its applicability even though all confounding factors are avoided.
Other Names:
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IC+CCRT-real-world database
Patients receiving IC+CCRT from real-world database
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5-year
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Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
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5-year
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Failure-free survival (FFS)
Time Frame: 5-year
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Failure-free survival is measured from day of diagnosis to locoregional failure, distant failure, or death from any cause, whichever occurred first.
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5-year
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Locoregional failure-free survival (LRFFS)
Time Frame: 5-year
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Locoregional failure-free survival is measured from day of diagnosis to first locoregional failure.
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5-year
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Distant failure-free survival (DFFS)
Time Frame: 5-year
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Distant failure-free survival is measured from day of diagnosis to distant failure.
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5-year
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Probability of studying/work stoppage caused by disease and treatment
Time Frame: 5-year
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Probability of learning (students who are in college/university/school before illness) or work (staff who are working before illness) stoppage due to illness and treatment.
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5-year
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Probability of returning to studying/work after suspending
Time Frame: 5-year
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Probability of returning to learning (students who are in college/university/school before illness) or work (staff who are working before illness) after suspending due to illness and treatment.
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5-year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of radioactive brain injury
Time Frame: 5-year
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Incidence of radioactive brain injury according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of hearing loss
Time Frame: 5-year
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Incidence of hearing loss according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of blind
Time Frame: 5-year
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Incidence of blind according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of decreased taste
Time Frame: 5-year
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Incidence of decreased taste according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of second cancer
Time Frame: 5-year
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Incidence of second cancer according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of dysphagia
Time Frame: 5-year
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Incidence of dysphagia according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of malnutrition
Time Frame: 5-year
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Incidence of malnutrition according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Incidence of hypothyroidism
Time Frame: 5-year
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Incidence of hypothyroidism according to the Common Terminology Criteria for Adverse Events (version 4.0).
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5-year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jun Ma, Professor, Sun Yat-sen University
Publications and helpful links
General Publications
- Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. doi: 10.1016/S1470-2045(11)70320-5. Epub 2011 Dec 7.
- Prince RM, Atenafu EG, Krzyzanowska MK. Hospitalizations During Systemic Therapy for Metastatic Lung Cancer: A Systematic Review of Real World vs Clinical Trial Outcomes. JAMA Oncol. 2015 Dec;1(9):1333-9. doi: 10.1001/jamaoncol.2015.3440.
- Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.
- Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.
- Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer. 2014 Feb 4;110(3):551-5. doi: 10.1038/bjc.2013.725. Epub 2014 Jan 14. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- 2019-FXY-239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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