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A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT00705627
Recruitment Status : Unknown
Verified May 2014 by Hong Ming-huang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 26, 2008
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

Locoregionally 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 locoregionally 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 locoregionally 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 or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : June 2008
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: B
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: 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.
Other Name: Neoadjuvant Chemotherapy Followed by CCRT

Outcome Measures

Primary Outcome Measures :
  1. distant metastasis free survival,disease free survival [ Time Frame: 5-Yr ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5-Yr ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705627

Contact: Sumei Cao, Ph. D. 86-20-8734-5685 caosumei@mail/sysu.edu.cn

China, Guangdong
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Sumei Cao, Ph. D    86-20-8734-5685    caosumei@mail.sysu.edu.cn   
Principal Investigator: Minghuang Hong, MD         
Sponsors and Collaborators
Sun Yat-sen University
Guangdong General Hospital
Cancer Center of Guangzhou Medical University
Cancer Hospital of Shantou University
Study Chair: Minghuang Hong, MD Sun Yet sen Cancer Center, China
More Information

Responsible Party: Hong Ming-huang, the director of GCP, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00705627     History of Changes
Other Study ID Numbers: 2007047
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Hong Ming-huang, Sun Yat-sen University:
nasopharyngeal carcinoma
neoadjuvant chemotherapy
concurrent chemotherapy
randomized controlled clinical trials

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents