Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This study is currently recruiting participants.

Verified August 2012 by Sun Yat-sen University

Sponsor:

Collaborators:

Fudan University

West China Hospital

Huazhong University of Science and Technology

Beijing Cancer Hospital

Zhejiang Cancer Hospital

Central South University

Jiangsu Cancer Institute & Hospital

The First People's Hospital of Foshan

The Third Affiliated Hospital of Harbin Medical University

Guangxi Medical University

Jiangxi Cancer Hospital

Guangzhou Medical University Cancer Institute and Hospital

Information provided by (Responsible Party):

Jun Ma, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT01245959

First received: November 22, 2010

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Drug: Docetaxel, cisplatin and fluorouracil Radiation: Concurrent chemoradiotherapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

Failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Secondary Outcome Measures:

Overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Overall survival is calculated from randomization to death from any cause.
Locoregional failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
The latency (ie, time from randomisation) to the first locoregional failure
Distant failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
The latency (ie, time from randomisation) to the first remote failure
The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy ] [ Designated as safety issue: No ]
Toxic effects [ Time Frame: During and after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	476
Study Start Date:	January 2011
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Induction chemotherapy and concurrent chemoradiotherapy 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 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. Other Name: TPF induction chemotherapy Radiation: Concurrent chemoradiotherapy Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Other Name: Radical radiotherapy and concurrent cisplatin
Active Comparator: Concurrent chemoradiotherapy Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.	Radiation: Concurrent chemoradiotherapy Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Other Name: Radical radiotherapy and concurrent cisplatin

Arms

Assigned Interventions

Experimental: Induction chemotherapy and concurrent chemoradiotherapy

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

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.

Other Name: TPF induction chemotherapy

Radiation: Concurrent chemoradiotherapy

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

Other Name: Radical radiotherapy and concurrent cisplatin

Active Comparator: Concurrent chemoradiotherapy

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

Radiation: Concurrent chemoradiotherapy

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

Other Name: Radical radiotherapy and concurrent cisplatin

Detailed Description:

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm 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. Patients are stratified according to the treatment centers and stage. The primary end point is failure-free survival (FFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245959

Contacts

Contact: Jun Ma, M.D.

+86-20-87343469

majun2@mail.sysu.edu.cn

Locations

China, Guangdong
Sun Yat-sen University Cancer Center	Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jun Ma, M.D. +86-20-87343469 majun2@mail.sysu.edu.cn
Principal Investigator: Jun Ma, M.D.

Sponsors and Collaborators

Sun Yat-sen University

Fudan University

West China Hospital

Huazhong University of Science and Technology

Beijing Cancer Hospital

Zhejiang Cancer Hospital

Central South University

Jiangsu Cancer Institute & Hospital

The First People's Hospital of Foshan

The Third Affiliated Hospital of Harbin Medical University

Guangxi Medical University

Jiangxi Cancer Hospital

Guangzhou Medical University Cancer Institute and Hospital

Investigators

Study Chair:

Jun Ma, M.D.

Sun Yat-sen University

More Information

Publications:

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

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.

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. 2010 Jul 17; [Epub ahead of print]

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. Review.

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.

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.

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.

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.

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.

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.

Responsible Party:	Jun Ma, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT01245959 History of Changes
Other Study ID Numbers:	YP2010171
Study First Received:	November 22, 2010
Last Updated:	August 9, 2012
Health Authority:	China: Ethics Committee

Keywords provided by Sun Yat-sen University:

Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Induction chemotherapy
Clinical trial

Additional relevant MeSH terms:

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

Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013

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