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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sun Yat-sen University
Sponsor:
Collaborators:
Guangdong General Hospital
Cancer Center of Guangzhou Medical University
Cancer Hospital of Shantou University
Information provided by (Responsible Party):
Hong Ming-huang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00705627
First received: June 24, 2008
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Nasopharyngeal Carcinoma
Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 2017
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Sumei Cao, Ph. D. 86-20-8734-5685 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    86-20-8734-5685    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
Investigators
Study Chair: Minghuang Hong, MD Sun Yet sen Cancer Center, China
  More Information

No publications provided

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
Study First Received: June 24, 2008
Last Updated: May 26, 2014
Health Authority: China: Ministry of Health

Keywords provided by 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
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014