GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC
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|ClinicalTrials.gov Identifier: NCT03604965|
Recruitment Status : Unknown
Verified July 2018 by Feng Jing, Guiyang Medical University.
Recruitment status was: Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Nasopharyngeal Carcinoma||Drug: GP+CCRT Drug: TPF+CCRT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized Controlled Phase III Clinical Trial of GP Induction Chemotherapy With TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma|
|Actual Study Start Date :||July 21, 2018|
|Estimated Primary Completion Date :||July 21, 2020|
|Estimated Study Completion Date :||July 21, 2020|
GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
Patients receive Neoadjuvant gemcitabine (1000mg/m2 on day1 and day8 ) and cisplatin (80mg/m2 on day1)every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
Other Name: Experimental group
Active Comparator: TPF+CCRT
TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
Other Name: Control group
- Progress-free survival(PFS) [ Time Frame: 3 years ]Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
- Overall survival(OS) [ Time Frame: 3 years ]The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
- Locoregional failure-free survival(LRFS) [ Time Frame: 3 years ]The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
- Distant metastasis-free survival(DMFS) [ Time Frame: 3 years ]The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
- Overall response rate [ Time Frame: 3 years ]Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1
- Incidence of acute and late toxicity [ Time Frame: 3 years ]Incidence of acute toxicity（Grade1/2/3/4） is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604965
|Contact: Feng Jin, Bacheloremail@example.com|
|Contact: Yuanyuan Li, Masterfirstname.lastname@example.org|
|Cancer Hospital of Guizhou Medical University||Recruiting|
|Guiyang, 贵州省, China, 550000|
|Contact: Yuanyuan Li, master 085186512802 email@example.com|
|Sub-Investigator: Feng Jin, Bachelor|
|Sub-Investigator: Weili Wu, Master|
|Sub-Investigator: Jinhua Long, Master|
|Sub-Investigator: Xiuling Luo, Bachelor|
|Sub-Investigator: Xiuyun Gong, Bachelor|
|Sub-Investigator: Yanfang Cen, Bachelor|
|Principal Investigator:||Yuanyuan Li, Master||Guizhou Provincial Cancer Hospital|