Clinical trial NCT02940925: TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma
Official title: TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
induction chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.

Detailed description: This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS）.The secondary endpoints are overall survival(OS）,progression-free survival（PFS）, local-regionally relapse free survival(LRFS), distant metastasis free survival（DMFS)and toxicities.

Eligibility criteria: Inclusion Criteria:

* WHO II or III pathological type
* stage Ⅳa or Ⅳb (UICC 7th edition)
* no anticancer treatment before
* no malignant history
* both gender, 18-60 years old
* enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
* enough kidney function: Clcr≥80 mL/min
* enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
* no sever heart, lung disfunction
* PS≤2

Exclusion Criteria:

* previous anticancer treatment
* distant metastasis
* pregnant or breasting female
* can not access to followup
* enrolled in other therapeutic clinical trial
* sever infection and internal disease
* sever disfunction of heart, lung, kidney, liver, etc
* TBIL\>ULN；AST/ALT\>2.5×ULN；ALP\>5×ULN
* with factors that will affect the administration, distribution,metabolism or evacuation.
* using immunosuppressive agents after organ transplantation
* other malignant history

Primary outcomes:
measure: Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
timeFrame: up to 5 years
Secondary outcomes:
measure: Overall survival calculated from randomisation to death from any cause
timeFrame: up to 5 years
measure: Progression free survival calculated from randomisation to disease progression or death from any cause
timeFrame: up to 5 years
measure: Local-regionally relapse free survival calculated from randomisation to locoregional failure
timeFrame: up to 5 years
measure: Distant metastasis free survival calculated from randomisation to distant failure
timeFrame: up to 5 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-senU
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanqun Xiang
role: STUDY_CHAIR
affiliation: Cancer Center of Guangzhou medical school
name: Taize Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Hospital
name: Yunxiang He
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hui EP, Ma BB, Leung SF, King AD, Mo F, Kam MK, Yu BK, Chiu SK, Kwan WH, Ho R, Chan I, Ahuja AT, Zee BC, Chan AT. Randomized phase II trial of concurrent cisplatin-radiotherapy with or without neoadjuvant docetaxel and cisplatin in advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Jan 10;27(2):242-9. doi: 10.1200/JCO.2008.18.1545. Epub 2008 Dec 8.
citation: Chan AT, Ma BB, Lo YM, Leung SF, Kwan WH, Hui EP, Mok TS, Kam M, Chan LS, Chiu SK, Yu KH, Cheung KY, Lai K, Lai M, Mo F, Yeo W, King A, Johnson PJ, Teo PM, Zee B. Phase II study of neoadjuvant carboplatin and paclitaxel followed by radiotherapy and concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma: therapeutic monitoring with plasma Epstein-Barr virus DNA. J Clin Oncol. 2004 Aug 1;22(15):3053-60. doi: 10.1200/JCO.2004.05.178.
citation: Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.
citation: Lee AW, Ngan RK, Tung SY, Cheng A, Kwong DL, Lu TX, Chan AT, Chan LL, Yiu H, Ng WT, Wong F, Yuen KT, Yau S, Cheung FY, Chan OS, Choi H, Chappell R. Preliminary results of trial NPC-0501 evaluating the therapeutic gain by changing from concurrent-adjuvant to induction-concurrent chemoradiotherapy, changing from fluorouracil to capecitabine, and changing from conventional to accelerated radiotherapy fractionation in patients with locoregionally advanced nasopharyngeal carcinoma. Cancer. 2015 Apr 15;121(8):1328-38. doi: 10.1002/cncr.29208. Epub 2014 Dec 19.
citation: Gao Y, Huang HQ, Bai B, Cai QC, Wang XX, Cai QQ. Treatment outcome of docetaxel, capecitabine and cisplatin regimen for patients with refractory and relapsed nasopharyngeal carcinoma who failed previous platinum-based chemotherapy. Expert Opin Pharmacother. 2014 Feb;15(2):163-71. doi: 10.1517/14656566.2014.866652. Epub 2013 Dec 3.
citation: Li WZ, Lv X, Hu D, Lv SH, Liu GY, Liang H, Ye YF, Yang W, Zhang HX, Yuan TZ, Wang DS, Lu N, Ke LR, Tang WB, Tong LH, Chen ZJ, Liu T, Cao KJ, Mo HY, Guo L, Zhao C, Chen MY, Chen QY, Huang PY, Sun R, Qiu F, Luo DH, Wang L, Hua YJ, Tang LQ, Qian CN, Mai HQ, Guo X, Xiang YQ, Xia WX. Effect of Induction Chemotherapy With Paclitaxel, Cisplatin, and Capecitabine vs Cisplatin and Fluorouracil on Failure-Free Survival for Patients With Stage IVA to IVB Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):706-714. doi: 10.1001/jamaoncol.2022.0122.