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

NCT02940925 | Completed Phase 3 DMC

• 1 other identifier: 20160049
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; induction chemotherapy

Outcome Measures

Primary Outcomes (1)

• Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause

  up to 5 years

Secondary Outcomes (5)

• Overall survival calculated from randomisation to death from any cause

  up to 5 years

• Progression free survival calculated from randomisation to disease progression or death from any cause

  up to 5 years

• Local-regionally relapse free survival calculated from randomisation to locoregional failure

  up to 5 years

• Distant metastasis free survival calculated from randomisation to distant failure

  up to 5 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 5 years

Study Arms (2)

Drug: Taxol,cisplatin and capecitabine

EXPERIMENTAL

Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy \|(CCRT).

Other: Drug: Taxol,cisplatin and capecitabine

Drug: Cisplatin and 5-Fluorouracil

ACTIVE COMPARATOR

Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Other: Drug: Cisplatin and 5-Fluorouracil

Interventions

Drug: Taxol,cisplatin and capecitabine OTHER

Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Drug: Taxol,cisplatin and capecitabine

Drug: Cisplatin and 5-Fluorouracil OTHER

Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Drug: Cisplatin and 5-Fluorouracil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, 510060, China

Location

Related Publications (6)

• 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.

  PMID: 19064973 BACKGROUND

• 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.

  PMID: 15284255 BACKGROUND

• 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.

  PMID: 17960012 BACKGROUND

• 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.

  PMID: 25529384 BACKGROUND

• 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.

  PMID: 24295173 BACKGROUND

• 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.

  PMID: 35323856 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Paclitaxel; Cisplatin; Capecitabine; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yanqun Xiang

  Sun Yat-sen University

  STUDY CHAIR

• Taize Yuan

  Cancer Center of Guangzhou medical school

  PRINCIPAL INVESTIGATOR

• Yunxiang He

  Xiangya Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 21, 2016
• Study Start: October 20, 2016
• Primary Completion: August 28, 2021
• Study Completion: August 31, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)