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

Sponsors and Collaborators:	Sun Yat-sen University Queen Mary Hospital; the Affiliated Tumor Hospital of Fu Dan University; Peking University Tongji Hospital of Tongji Medical College; Zhejiang Provincial Tumor Hospital; the Fifth Affiliated Hospital of Sun Yat-sen University; Guangdong Provincial People's Hospital
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00677118

Purpose

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

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Drug: cisplatin,fluorouracil Drug: cisplatin	Phase III

Drug Information available for: Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy to Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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

Primary Outcome Measures:

disease free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	506
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental concurrent chemoradiotherapy plus adjuvant chemotherapy	Drug: cisplatin,fluorouracil Patients received radical radiotherapy, and cisplatin (40mg/m2 on day 1) weekly during RT, then received cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of RT.
2: Active Comparator concurrent chemoradiotherapy	Drug: cisplatin Patients in the control arm received radical radiotherapy, and cisplatin (40mg/m2 on day 1) weekly during RT.

Detailed Description:

Patients presented with non-keratinizing or undifferentiated NPC and stage T3-4N1M0/TxN2-3M0 were randomly assigned to receive concurrent chemoradiotherapy (control arm) or concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm). Patients in both arms received radical radiotherapy, and cisplatin (40mg/m2 on day 1) weekly during RT. Patients in the investigational arm received cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. Overall survival (OS), disease free survival (DFS), distant failure-free survival (D-FFS) and locoregional failure-free survival (LR-FFS) were compared between two arms. Toxicity and treatment compliance were evaluated. The Kaplan-Meier product-limit method was used in the calculation of the survival analysis. The statistical significance of difference among survival curves was analyzed using the log-rank test. Toxicity and tumor response were compared using the χ2 test.

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing or undifferentiated carcinoma (according to WHO histologically type)
Tumor staged as N2-3or T3-4N1 (according to 6th AJCC/UICC staging system)
No evidence of distant metastasis (M0)
Performance status: KPS≥70
With normal liver function test (ALT、AST≤2.5×ULN)
Renal: creatinine clearance≥60ml/min
Without hematopathy, marrow: WBC≥ 4×109/L,HGB≥80g/L and PLT≥100×109/L
Written informed consent

Exclusion Criteria:

WHO type I squamous cell carcinoma or adenocarcinoma
Age≥70 or≤16
With a history of renal disease
Prior malignancy
Previous chemotherapy or radiotherapy
Patient is pregnant or lactating
Emotion disturbance
Evidence of distant metastasis among or three months after the time of radiotherapy

Contacts and Locations

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

Contacts

Contact: Jun Ma, M.D.

+86-20-87343469

drjunma@hotmail.com

Locations

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

Queen Mary Hospital;

the Affiliated Tumor Hospital of Fu Dan University;

Peking University

Tongji Hospital of Tongji Medical College;

Zhejiang Provincial Tumor Hospital;

the Fifth Affiliated Hospital of Sun Yat-sen University;

Guangdong Provincial People's Hospital

Investigators

Study Chair:

Jun Ma, M.D.

Sun Yat-sen University

More Information

Responsible Party:	Sun Yat-sen University ( Sun Yat-sen University )
Study ID Numbers:	NPC-5010 Trial, 5010
Study First Received:	May 9, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00677118
Health Authority:	China: Ethics Committee

Keywords provided by Sun Yat-sen University:

Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Adjuvant chemotherapy
Clinical trial

Study placed in the following topic categories:

Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cisplatin
Fluorouracil
Head and Neck Neoplasms

Pharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on January 14, 2009