Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma - Full Text View

Purpose

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Drug: Cisplatin,fluorouracil Drug: Cisplatin	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:	A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy 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

U.S. FDA Resources

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

Primary Outcome Measures:

Failure-free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Secondary Outcome Measures:

Overall survival, distant failure-free survival and locoregional failure-free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]
Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.

Estimated Enrollment:	506
Study Start Date:	June 2006
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Concurrent and adjuvant Concurrent chemoradiotherapy plus adjuvant chemotherapy	Drug: Cisplatin,fluorouracil Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Other Name: Cisplatin and fluorouracil
Active Comparator: Concurrent Concurrent chemoradiotherapy	Drug: Cisplatin Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Other Name: Cisplatin

Detailed Description:

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
No evidence of distant metastasis (M0)
Performance status: KPS ≥70
With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
Renal: creatinine clearance ≥60ml/min
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
Written informed consent

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥70 or <18
With a history of renal disease
Prior malignancy
Previous chemotherapy or radiotherapy
Patient is pregnant or lactating
Unstable cardiac disease requiring treatment.
Emotion disturbance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677118

Locations

China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Sun Yat-sen University

Fudan University

Zhejiang Cancer Hospital

Huazhong University of Science and Technology

Fifth Affiliated Hospital, Sun Yat-Sen University

Beijing Cancer Hospital

Guangdong General Hospital

Investigators

Study Chair:

Jun Ma, M.D.

Sun Yat-sen University

More Information

Publications:

Chua DT, Sham JS, Kwong DL, Au GK. Treatment outcome after radiotherapy alone for patients with Stage I-II nasopharyngeal carcinoma. Cancer. 2003 Jul 1;98(1):74-80.

Ma J, Mai HQ, Hong MH, Cui NJ, Lu TX, Lu LX, Mo HY, Min HQ. Is the 1997 AJCC staging system for nasopharyngeal carcinoma prognostically useful for Chinese patient populations? Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1181-9.

Zhao C, Han F, Lu LX, Huang SM, Lin CG, Deng XW, Lu TX, Cui NJ. [Intensity modulated radiotherapy for local-regional advanced nasopharyngeal carcinoma]. Ai Zheng. 2004 Nov;23(11 Suppl):1532-7. Chinese.

Lee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22.

Kam MK, Teo PM, Chau RM, Cheung KY, Choi PH, Kwan WH, Leung SF, Zee B, Chan AT. Treatment of nasopharyngeal carcinoma with intensity-modulated radiotherapy: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1440-50.

Decker DA, Drelichman A, Al-Sarraf M, Crissman J, Reed ML. Chemotherapy for nasopharyngeal carcinoma. A ten-year experience. Cancer. 1983 Aug 15;52(4):602-5.

Al-Sarraf M. Chemotherapeutic management of head and neck cancer. Cancer Metastasis Rev. 1987;6(3):181-98. Review.

Rossi A, Molinari R, Boracchi P, Del Vecchio M, Marubini E, Nava M, Morandi L, Zucali R, Pilotti S, Grandi C, et al. Adjuvant chemotherapy with vincristine, cyclophosphamide, and doxorubicin after radiotherapy in local-regional nasopharyngeal cancer: results of a 4-year multicenter randomized study. J Clin Oncol. 1988 Sep;6(9):1401-10.

Chi KH, Chang YC, Guo WY, Leung MJ, Shiau CY, Chen SY, Wang LW, Lai YL, Hsu MM, Lian SL, Chang CH, Liu TW, Chin YH, Yen SH, Perng CH, Chen KY. A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1238-44.

Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. Epub 2011 Dec 7.

Responsible Party:	Jun Ma, Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier:	NCT00677118 History of Changes
Other Study ID Numbers:	YP2008004
Study First Received:	May 9, 2008
Last Updated:	May 9, 2011
Health Authority:	China: Ethics Committee

Keywords provided by Sun Yat-sen University:

Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Adjuvant 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

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

ClinicalTrials.gov processed this record on May 23, 2013