Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
NCT ID: NCT02937519
Last Updated: 2018-06-06
Study Results
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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UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2015-06-30
2018-06-30
Brief Summary
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2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.
3）observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Melodie group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Chrono-chemotherapy pump:Melodie
induction Chrono-chemotherapy
cisplatin chrono-chemotherapy
intensity-modulated radiation therapy
Routine-Chemotherapy
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Routine intravenous drip
induction Routine-chemotherapy
cisplatin routine-chemotherapy
intensity-modulated radiation therapy
Interventions
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Chrono-chemotherapy pump:Melodie
Routine intravenous drip
induction Chrono-chemotherapy
induction Routine-chemotherapy
cisplatin chrono-chemotherapy
cisplatin routine-chemotherapy
intensity-modulated radiation therapy
Eligibility Criteria
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Inclusion Criteria
* KPS≥70 points.
* the age of 18-70 years old, male or female.
* no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
* understand this study and signed informed consent.
Exclusion Criteria
* who had received prior chemotherapy.
* patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
* pregnancy (via the urine or serum β-HCG test confirmed) or during lactation.
* serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
18 Years
70 Years
ALL
No
Sponsors
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The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
UNKNOWN
Sun Yat-sen University
OTHER
Guiyang Medical University
OTHER
Responsible Party
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Feng Jing
Chief physician/Professor
Locations
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Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016080201
Identifier Type: -
Identifier Source: org_study_id
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