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Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT02937519
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : June 5, 2018
Sponsor:
Collaborators:
The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
Sun Yat-sen University
Information provided by (Responsible Party):
Feng Jing, Guiyang Medical University

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date June 5, 2018
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2016)
  • Number of Participants with curative effect [ Time Frame: 1 year ]
    Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 5 years ]
    To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02937519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2016)
  • Progression-free survival [ Time Frame: 5 years ]
    Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
  • Overall survival [ Time Frame: 5 years ]
    Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
Official Title  ICMJE Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
Brief Summary
  1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma.
  2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.

3)observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Neoplasms
Intervention  ICMJE
  • Device: Chrono-chemotherapy pump:Melodie
  • Device: Routine intravenous drip
  • Drug: induction Chrono-chemotherapy
  • Drug: induction Routine-chemotherapy
  • Drug: cisplatin chrono-chemotherapy
  • Drug: cisplatin routine-chemotherapy
  • Radiation: intensity-modulated radiation therapy
Study Arms  ICMJE
  • Experimental: Melodie group
    Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
    Interventions:
    • Device: Chrono-chemotherapy pump:Melodie
    • Drug: induction Chrono-chemotherapy
    • Drug: cisplatin chrono-chemotherapy
    • Radiation: intensity-modulated radiation therapy
  • Routine-Chemotherapy
    Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
    Interventions:
    • Device: Routine intravenous drip
    • Drug: induction Routine-chemotherapy
    • Drug: cisplatin routine-chemotherapy
    • Radiation: intensity-modulated radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
  • KPS≥70 points.
  • the age of 18-70 years old, male or female.
  • no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
  • understand this study and signed informed consent.

Exclusion Criteria:

  • distant metastasis.
  • who had received prior chemotherapy.
  • patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
  • pregnancy (via the urine or serum β-HCG test confirmed) or during lactation.
  • serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hang Jiang, Bachelor degree 0851-86512802 233956010@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02937519
Other Study ID Numbers  ICMJE 2016080201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Feng Jing, Guiyang Medical University
Study Sponsor  ICMJE Guiyang Medical University
Collaborators  ICMJE
  • The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
  • Sun Yat-sen University
Investigators  ICMJE Not Provided
PRS Account Guiyang Medical University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP