Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02111460
• Other study ID #: SYSUCC5010
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: December 2022
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patients with initial untreated metastatic nasopharyngeal carcinoma

• Histologic diagnosis of nasopharyngeal carcinoma

• T1-4N0-3M1,IVC(according to the 7th AJCC edition)

• Aged between 18 and 65 years

• KPS=70

• The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu

• Voluntary to participate and sign informed consent document

Exclusion Criteria:

• The patients suffered from serious neurologic disease

• Clinically significant cardiac, heart function less than or equal to 3 level

• Clinically significant respiratory disease,lung function less than or equal to 3 level

• Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L

• Abnormal liver function: total bilirubin or ALT or AST>2×ULN

• Abnormal renal function:serum creatinine>1.5×ULN

• Pregnant or lactating women

• The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Loco-regional Radiotherapy
with or without Loco-regional Radiotherapy

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.	2 years
Secondary	Progress-free survival	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.	2 years
Secondary	Complete Response (CR)	CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.	after the completion of the chemoradiotherapy treatment (up to 9 weeks)