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

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Loco-regional Radiotherapy

• Registration Number: NCT02111460
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-11
• Primary Completion: 2019-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Loco-regional Radiotherapy	Systemic Chemotherapy Combined with Loco-regional Radiotherapy
Chemotherapy	Loco-regional Radiotherapy	Chemotherapy alone without Loco-regional Radiotherapy

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Progress-free survival	2 years	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
Complete Response (CR)	after the completion of the chemoradiotherapy treatment (up to 9 weeks)	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.

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China