Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT01245959 | Unknown Phase 3 DMC

• 1 other identifier: YP2010171
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; Concurrent chemoradiotherapy; Induction chemotherapy; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

  3-year

Secondary Outcomes (5)

• Overall survival

  3-year

• Locoregional failure-free survival

  3-year

• Distant failure-free survival

  3-year

• The initial response rates after treatments

  A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy

• Toxic effects

  During and after treatment

Study Arms (2)

Induction chemotherapy and concurrent chemoradiotherapy

EXPERIMENTAL

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Drug: Docetaxel, cisplatin and fluorouracil; Radiation: Concurrent chemoradiotherapy

Concurrent chemoradiotherapy

ACTIVE COMPARATOR

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Radiation: Concurrent chemoradiotherapy

Interventions

Docetaxel, cisplatin and fluorouracil DRUG

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

Also known as: TPF induction chemotherapy

Induction chemotherapy and concurrent chemoradiotherapy

Concurrent chemoradiotherapy RADIATION

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Also known as: Radical radiotherapy and concurrent cisplatin

Concurrent chemoradiotherapy; Induction chemotherapy and concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
• Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition).
• No evidence of distant metastasis (M0).
• Satisfactory performance status: Karnofsky scale (KPS) \> 70.
• Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
• Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
• Adequate renal function: creatinine clearance ≥60 ml/min.
• Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
• Age ≥60 years or \<18 years.
• Treatment with palliative intent.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation.
• History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
• Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fudan University: collaborator
• West China Hospital: collaborator
• Huazhong University of Science and Technology: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Zhejiang Cancer Hospital: collaborator
• Central South University: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• First People's Hospital of Foshan: collaborator
• The Third Affiliated Hospital of Harbin Medical University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• Guangzhou Medical University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (16)

• Cancer incidence in five continents. Volume VIII. IARC Sci Publ. 2002;(155):1-781. No abstract available.

  PMID: 12812229 BACKGROUND

• Stephen B. Edge, David R. Byrd, Carolyn C. Compton, April G. Fritz, Frederick L. Greene, and Andy Trotti. AJCC Cancer Staging Manual. 7th ed. New York: Springer, 2009: 41-46.

  BACKGROUND

• Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.

  PMID: 20643517 BACKGROUND

• Baujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037.

  PMID: 16377415 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

• Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

  PMID: 17960013 BACKGROUND

• Qin-Hua Zhang, Wei Luo, Qi-Chao Zhou, Zhan Yu, Jun Ma, Meng-Zhong Liu. TPF induction chemotherapy followed by intensity-modulated radiotherapy and concomitant chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Chinese Journal of Cancer Prevention and Treatment 16(8): 625-628, 2009.

  BACKGROUND

• Guo L, Lin HX, Xu M, Chen QY, Wang CT, Huang PY. Phase I study of TPF neoadjuvant chemotherapy followed by radical radiotherapy in advanced nasopharyngeal carcinoma. Chin J Cancer. 2010 Feb;29(2):136-9. doi: 10.5732/cjc.009.10367.

  PMID: 20109339 BACKGROUND

• Friedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. New York: Springer-Verlag; 1998.

  BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.

  PMID: 7713792 BACKGROUND

• Chow, S.C., Shao, J., Wang, H. Sample Size Calculations in Clinical Research. New York: Marcel Dekker; 2003.

  BACKGROUND

• Dong D, Zhang F, Zhong LZ, Fang MJ, Huang CL, Yao JJ, Sun Y, Tian J, Ma J, Tang LL. Development and validation of a novel MR imaging predictor of response to induction chemotherapy in locoregionally advanced nasopharyngeal cancer: a randomized controlled trial substudy (NCT01245959). BMC Med. 2019 Oct 23;17(1):190. doi: 10.1186/s12916-019-1422-6.

  PMID: 31640711 DERIVED

• Zhang Y, Li WF, Liu X, Chen L, Sun R, Sun Y, Liu Q, Ma J. Nomogram to predict the benefit of additional induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Analysis of a multicenter, phase III randomized trial. Radiother Oncol. 2018 Oct;129(1):18-22. doi: 10.1016/j.radonc.2017.12.002. Epub 2017 Dec 16.

  PMID: 29258695 DERIVED

• Li WF, Chen L, Sun Y, Ma J. Induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Chin J Cancer. 2016 Nov 15;35(1):94. doi: 10.1186/s40880-016-0157-4.

  PMID: 27846913 DERIVED

• Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.

  PMID: 27686945 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Docetaxel; Cisplatin; Fluorouracil; Chemoradiotherapy

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; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Jun Ma, M.D.

  Sun Yat-sen University

  STUDY CHAIR

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

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2018
• Last Updated: February 13, 2014

Record last verified: 2014-01

Locations

CN (1)