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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

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.


Condition or disease Intervention/treatment Phase
Esophageal Neoplasms 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Melodie group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
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
Device: Routine intravenous drip
Drug: induction Routine-chemotherapy
Drug: cisplatin routine-chemotherapy
Radiation: intensity-modulated radiation therapy



Primary Outcome Measures :
  1. Number of Participants with curative effect [ Time Frame: 1 year ]
    Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.

  2. 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.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5 years ]
    Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.

  2. Overall survival [ Time Frame: 5 years ]
    Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02937519


Contacts
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Contact: Hang Jiang, Bachelor degree 0851-86512802 233956010@qq.com

Locations
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China, Guizhou
Cancer Hospital of Guizhou Medical University Recruiting
Guiyang, Guizhou, China, 550000
Contact: Feng Jin, Bachelor    0851-86512802    jinf8865@yahoo.com.cn   
Principal Investigator: Feng Jin, Bachelor         
Sub-Investigator: Ling Guo, Doctor         
Sub-Investigator: Ling Wu, Bachelor         
Sub-Investigator: Weili Wu, master         
Sub-Investigator: Jinhua Long, master         
Sub-Investigator: Yuanyuan Li, master         
Sub-Investigator: Xiuyun Gong, Bachelor         
Sub-Investigator: Xiaoxiao Chen, Bachelor         
Sub-Investigator: Zhuoling Li, master         
Sub-Investigator: Hang Jiang, Bachelor         
Sponsors and Collaborators
Guiyang Medical University
The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
Sun Yat-sen University

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Responsible Party: Feng Jing, Chief physician/Professor, Guiyang Medical University
ClinicalTrials.gov Identifier: NCT02937519     History of Changes
Other Study ID Numbers: 2016080201
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Feng Jing, Guiyang Medical University:
Chronomodulated Chemotherapy
Intensity Modulated Radiation Therapy
Advanced Nasopharyngeal Cancer

Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Esophageal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Carcinoma
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Antineoplastic Agents