TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940925
• Other study ID #: 20160049
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2016
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: August 31, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• WHO II or III pathological type

• stage ?a or ?b (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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Other:
• Drug: Taxol,cisplatin and capecitabine
Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
• Drug: Cisplatin and 5-Fluorouracil
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Locations

Country	Name	City	State
China	SunYat-senU	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Erratum In: Cancer. 2020 Jan 15;126(2):454-455. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause		up to 5 years
Secondary	Overall survival calculated from randomisation to death from any cause		up to 5 years
Secondary	Progression free survival calculated from randomisation to disease progression or death from any cause		up to 5 years
Secondary	Local-regionally relapse free survival calculated from randomisation to locoregional failure		up to 5 years
Secondary	Distant metastasis free survival calculated from randomisation to distant failure		up to 5 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		up to 5 years