Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT01528618 |
Recruitment Status :
Completed
First Posted : February 8, 2012
Last Update Posted : October 4, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | January 31, 2012 | |||
First Posted Date ICMJE | February 8, 2012 | |||
Last Update Posted Date | October 4, 2021 | |||
Actual Study Start Date ICMJE | February 21, 2012 | |||
Actual Primary Completion Date | April 10, 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression free survival (PFS) assessed by independent image committee and the investigators [ Time Frame: 36 months ] | |||
Original Primary Outcome Measures ICMJE |
Progression free survival (PFS) [ Time Frame: 36 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma | |||
Official Title ICMJE | A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) | |||
Brief Summary | The present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0. | |||
Detailed Description | Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China ,where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. NPC is a radiosensitive tumor, and radiotherapy is considered to be the treatment of choice for most cases. The 5-year survival rate (all stages) is around 50% .In other words, more than half of the NPC cases will eventually fail radiotherapy and reasons of the failure are both local relapse and remote metastasis. For these advanced or metastatic NPC, chemotherapy is the most important therapeutics,and they are relatively responsive to chemotherapy compared to other head and neck cancers. The backbone of the treatment for recurrent/metastatic (R/M) NPC is cisplatin containing regimen, which is also regarded as the standard regimen for other squamous cell carcinoma of head and neck (SCCHN). The FP regimen is widely used in R/M NPC patients now and its response rate is around 40%-65%,but the response period is usually short and the adverse reaction is frequent and badly tolerant, which influent the treatment compliance seriously. What's more, the catheters and pumps are necessary for continuous infusion of 5-Fluorouracil, which add to the cost, immobility and inconvenience of the treatment. Preclinical and clinical data show synergistic activity between gemcitabine and cisplatin without overlapping toxicity. Several clinical trials enrolling a minority of advanced NPC patients suggest GP regimen has promising effectiveness and well tolerated side effects, and they indicated a potential possibility that the GP regimen comes to the standard first line choice instead of the FP regimen |
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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 Neoplasms | |||
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 | Completed | |||
Actual Enrollment ICMJE |
362 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 20, 2020 | |||
Actual Primary Completion Date | April 10, 2016 (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 and older (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 | NCT01528618 | |||
Other Study ID Numbers ICMJE | GEM20110714 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Li Zhang, MD, Sun Yat-sen University | |||
Original Responsible Party | Li Zhang, Sun Yat-sen University, professor | |||
Current Study Sponsor ICMJE | Sun Yat-sen University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sun Yat-sen University | |||
Verification Date | September 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |