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Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187315
Recruitment Status : Unknown
Verified July 2014 by Feng Jing, Guiyang Medical University.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Feng Jing, Guiyang Medical University

Brief Summary:
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, 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
Nasopharyngeal Carcinoma Device: Chrono-chemotherapy pump:Melodie Device: Routine intravenous drip Drug: induction chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy Drug: cisplatin routine-chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Number of Participants with curative effect [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
  2. Karnofsky score≥70;
  3. Age 18-70 years old, male or female;
  4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4.0×109/L,platelet≥100×109 /L. hemoglobin ≥100g/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 the upper limit of normal) electrocardiogram does not affect the normal treatment;
  5. To understand this study and sign informed consent form.

Exclusion Criteria:

  1. A distant metastasis;
  2. Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
  3. Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
  4. Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.

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): NCT02187315


Contacts
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Contact: Feng Jin, Professor +86 13985124806 jinf8865@gmail.com

Locations
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China, Guizhou
The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital Recruiting
Guiyang, Guizhou, China, 550001
Contact: Feng Jin, Professor    +86 13985124806    jinf8865@gmail.com   
Sponsors and Collaborators
Feng Jing
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Responsible Party: Feng Jing, Guiyang Medical College, Guiyang Medical University
ClinicalTrials.gov Identifier: NCT02187315    
Other Study ID Numbers: 20140501
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Carcinoma
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
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents