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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00705627
• Other study ID #: 2007047
• Status: Recruiting
• Phase: Phase 3
• First received: June 24, 2008
• Last updated: May 26, 2014
• Start date: June 2008
• Est. completion date: June 2017

Study information

• Verified date: May 2014
• Source: Sun Yat-sen University
• Contact: Sumei Cao, Ph. D.
• Phone: 86-20-8734-5685
• Email: caosumei[@]mail/sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Center of Guangzhou Medical University, Cancer Hospital of Shantou University, Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distant metastasis free survival,disease free survival		5-Yr	Yes
Secondary	overall survival		5-Yr	Yes