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

June 2, 2018 updated by: Feng Jing, Guiyang Medical University

Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
        • Cancer Hospital of Guizhou Medical University
        • Contact:
        • Principal Investigator:
          • Feng Jin, Bachelor
        • Sub-Investigator:
          • Ling Guo, Doctor
        • Sub-Investigator:
          • Ling Wu, Bachelor
        • Sub-Investigator:
          • Zhuoling Li, master
        • Sub-Investigator:
          • Hang Jiang, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Melodie group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Radiation: intensity-modulated radiation therapy
Device: Chrono-chemotherapy pump:Melodie
Drug: induction Chrono-chemotherapy
Drug: cisplatin chrono-chemotherapy
OTHER: Routine-Chemotherapy
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Radiation: intensity-modulated radiation therapy
Device: Routine intravenous drip
Drug: induction Routine-chemotherapy
Drug: cisplatin routine-chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with curative effect
Time Frame: 1 year
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
1 year
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years
Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
5 years
Overall survival
Time Frame: 5 years
Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guiyang Medical University

Collaborators

Sun Yat-sen University
The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

October 16, 2016

First Posted (ESTIMATE)

October 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 2, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016080201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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