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

May 6, 2020 updated by: Ming-Yuan Chen, Sun Yat-sen University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival
Time Frame: 2 years
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)
Time Frame: 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.
after the completion of the chemoradiotherapy treatment (up to 9 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC5010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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