Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma
|ClinicalTrials.gov Identifier: NCT01528618|
Recruitment Status : Unknown
Verified January 2016 by Li Zhang, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : February 8, 2012
Last Update Posted : January 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Neoplasms||Drug: gemcitabine and cisplatin Drug: 5-Fluorouracil and cisplatin||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||362 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: gemcitabine and cisplatin
gemcitabine 1,000 mg/m2 over 30 to 60 minutes on days 1, 8, and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
Drug: gemcitabine and cisplatin
The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1 only
Other Name: GP
Active Comparator: 5-Fluorouracil and cisplatin
5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
Drug: 5-Fluorouracil and cisplatin
The FP regimen consists of 5-Fluorouracil 1,000 mg/m2/day which was administered as a continuous intravenous infusion for 96 hours after completion of the cisplatin on days 1( 80 mg/m2 i.v. infusion for 4 h)
Other Name: FP
- Progression free survival (PFS) assessed by independent image committee and the investigators [ Time Frame: 36 months ]
- Overall survival (OS) [ Time Frame: 36 months ]
- Objective response rate (ORR) [ Time Frame: 36 months ]
- Number of Participants with Adverse Events [ Time Frame: 36 months ]
- Quality of life [ Time Frame: 36 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528618
|Department of Medical Oncology,Cancer Center of Sun Yat-Sen University|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||li zhang, doctor||Sun Yat-sen University|