Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT01872962 |
Recruitment Status : Unknown
Verified April 2018 by Jun Ma, MD, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : April 24, 2018
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Sponsor:
Sun Yat-sen University
Collaborators:
Fudan University
West China Hospital
Tongji Hospital
Peking University
Zhejiang Cancer Hospital
First People's Hospital of Foshan
Cancer Hospital of Guangxi Medical University
Jiangxi Provincial Cancer Hospital
Xijing hospital of The fourth military medical university
Cancer Hospital of Guizhou Province
Affiliated Cancer Hospital of Shantou University Medical College
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Jun Ma, MD, Sun Yat-sen University
Tracking Information | ||||
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First Submitted Date ICMJE | May 31, 2013 | |||
First Posted Date ICMJE | June 7, 2013 | |||
Last Update Posted Date | April 24, 2018 | |||
Study Start Date ICMJE | November 2013 | |||
Estimated Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Failure-free survival [ Time Frame: 3-year ] Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma | |||
Official Title ICMJE | Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma | |||
Brief Summary | The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC patients. | |||
Detailed Description | Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Nasopharyngeal Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Actual Enrollment ICMJE |
480 | |||
Original Estimated Enrollment ICMJE |
476 | |||
Estimated Study Completion Date ICMJE | November 2020 | |||
Estimated Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01872962 | |||
Other Study ID Numbers ICMJE | B2013-022-01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Jun Ma, MD, Sun Yat-sen University | |||
Original Responsible Party | Jun Ma, Sun Yat-sen University, Professor | |||
Current Study Sponsor ICMJE | Sun Yat-sen University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Sun Yat-sen University | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |