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

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ClinicalTrials.gov Identifier: NCT02111460
Recruitment Status : Recruiting
First Posted : April 11, 2014
Last Update Posted : September 13, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Ming-Yuan Chen, 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Loco-regional Radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111460


Contacts
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Contact: Xiong Zou, MD 86-20-8734-2422 zouxiong@sysucc.org.cn

Locations
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China, Guangdong
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming y Chen, MD,PhD    86-20-8734-2422    chenmy@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Ming y Chen, MD,Phd Sun Yat-sen University

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Responsible Party: Ming-Yuan Chen, professor & chief physician, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02111460     History of Changes
Other Study ID Numbers: SYSUCC5010
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Ming-Yuan Chen, Sun Yat-sen University:
Initially
Untreated
Distant metastatic

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases