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

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

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

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: Loco-regional Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy; Systemic Chemotherapy Combined with Loco-regional Radiotherapy	Radiation: Loco-regional Radiotherapy; with or without Loco-regional Radiotherapy
Active Comparator: Chemotherapy; Chemotherapy alone without Loco-regional Radiotherapy	Radiation: Loco-regional Radiotherapy; with or without Loco-regional Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Ming y Chen, MD,Phd, Sun Yat-sen University

Publications and helpful links

General Publications

• You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2019
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Untreated; Initially; Distant metastatic
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: SYSUCC5010