A Multicenter Trial Comparing Multi-Course Chemotherapy in Local-Regionally Advanced Nasopharyngeal Carcinoma - Full Text View

Sponsors and Collaborators:	Sun Yat-sen University Guangdong Provincial People' Hospital Guangzhou Medical Colledge Affiliated Cancer Hospital
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00705627

Purpose

Loco-regionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of loco-regionally advanced NPC with high-risk metastasis.

In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and loco-regionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.

Condition	Intervention	Phase
Loco-Regionally Advanced Nasopharyngeal Carcinoma	Drug: cisplatin,fluorouracil (neoadjuvant chemotherapy plus concurrent chemoradiotherapy)	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Local-Regionally Advanced Nasopharyngeal Carcinoma

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

Primary Outcome Measures:

distant metastasis free survival,disease free survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

overall survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.	Drug: cisplatin,fluorouracil (neoadjuvant chemotherapy plus concurrent chemoradiotherapy) Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
Original clinical stage must be T4 or N2-3 （UICC 2002）
Male and no pregnant female
Age between 18-60
WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
With normal liver function test (ALT、AST≤2.5×ULN)
With normal renal function test (Creatinine ≤ 1.5×ULN)
Performance status scale ECOG grade 0，1
Without radiotherapy or chemotherapy
Patients must give signed informed consent

Exclusion Criteria:

Patients have evidence of relapse or distant metastasis
The presence of uncontrolled life-threatening illness
Receiving other ways of anti-cancer therapy
Receiving radiotherapy or chemotherapy
Investigator consider the patients can't finish the whole study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705627

Contacts

Contact: Sumei Cao, Ph. D.

86-20-8734-3643

caosumei@mail/sysu.edu.cn

Locations

China, Guangdong
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Sumei Cao, Ph. D 86-20-8734-3643 caosumei@mail.sysu.edu.cn
Principal Investigator: Minghuang Hong, MD

Sponsors and Collaborators

Sun Yat-sen University

Guangdong Provincial People' Hospital

Guangzhou Medical Colledge Affiliated Cancer Hospital

Investigators

Study Chair:

Minghuang Hong, MD

Sun Yet sen Cancer Center, China

More Information

Responsible Party:	Sun Yat-sen University Cancer Center ( Hong Ming-huang )
Study ID Numbers:	2007047
Study First Received:	June 24, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00705627
Health Authority:	China: Ministry of Health

Keywords provided by Sun Yat-sen University:

loco-regionally advanced nasopharyngeal carcinoma
neoadjuvant chemotherapy
concurrent chemotherapy
randomized controlled clinical trials

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 16, 2009