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

Primary Purpose

Esophageal Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chrono-chemotherapy pump:Melodie
Routine intravenous drip
induction Chrono-chemotherapy
induction Routine-chemotherapy
cisplatin chrono-chemotherapy
cisplatin routine-chemotherapy
intensity-modulated radiation therapy
Sponsored by
Guiyang Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Chronomodulated Chemotherapy, Intensity Modulated Radiation Therapy, Advanced Nasopharyngeal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Melodie group

Routine-Chemotherapy

Arm Description

Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy

Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Outcomes

Primary Outcome Measures

Number of Participants with curative effect
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
Number of Participants with Adverse Events as a Measure of Safety
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.

Secondary Outcome Measures

Progression-free survival
Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
Overall survival
Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.

Full Information

First Posted
August 16, 2016
Last Updated
June 2, 2018
Sponsor
Guiyang Medical University
Collaborators
The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02937519
Brief Title
Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guiyang Medical University
Collaborators
The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
Keywords
Chronomodulated Chemotherapy, Intensity Modulated Radiation Therapy, Advanced Nasopharyngeal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melodie group
Arm Type
Experimental
Arm Description
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Arm Title
Routine-Chemotherapy
Arm Type
Other
Arm Description
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Intervention Type
Device
Intervention Name(s)
Chrono-chemotherapy pump:Melodie
Intervention Type
Device
Intervention Name(s)
Routine intravenous drip
Intervention Type
Drug
Intervention Name(s)
induction Chrono-chemotherapy
Intervention Type
Drug
Intervention Name(s)
induction Routine-chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin chrono-chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin routine-chemotherapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Primary Outcome Measure Information:
Title
Number of Participants with curative effect
Description
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
Time Frame
1 year
Title
Number of Participants with Adverse Events as a Measure of Safety
Description
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
Time Frame
5 years
Title
Overall survival
Description
Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Jiang, Bachelor degree
Phone
0851-86512802
Email
233956010@qq.com
Facility Information:
Facility Name
Cancer Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
Phone
0851-86512802
Email
jinf8865@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
First Name & Middle Initial & Last Name & Degree
Ling Guo, Doctor
First Name & Middle Initial & Last Name & Degree
Ling Wu, Bachelor
First Name & Middle Initial & Last Name & Degree
Weili Wu, master
First Name & Middle Initial & Last Name & Degree
Jinhua Long, master
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li, master
First Name & Middle Initial & Last Name & Degree
Xiuyun Gong, Bachelor
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Chen, Bachelor
First Name & Middle Initial & Last Name & Degree
Zhuoling Li, master
First Name & Middle Initial & Last Name & Degree
Hang Jiang, Bachelor

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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