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Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02907710
Recruitment Status : Unknown
Verified September 2016 by min kang, First Affiliated Hospital of Guangxi Medical University.
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
min kang, First Affiliated Hospital of Guangxi Medical University

Tracking Information
First Submitted Date  ICMJE September 13, 2016
First Posted Date  ICMJE September 20, 2016
Last Update Posted Date September 20, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
3-year Progression Free Survival [ Time Frame: 3 years ]
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar,including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy,and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
5-year Overall Survival [ Time Frame: 5 years ]
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar,including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy,and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.
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 Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title  ICMJE A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
Brief Summary A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with high efficacy and low toxicity.
Detailed Description This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Five medical centers participated in this study and 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and concurrent chemoradiotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Endostar
    intravenous infusion
    Other Name: recombinant human endostatin
  • Drug: DDP
Study Arms  ICMJE
  • Experimental: concurrent chemoradiotherapy + endostar

    Drug: Endostar

    Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy

    Drug: DDP

    DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles

    Radiation: IMRT

    IMRT:70-74Gy

    Interventions:
    • Drug: Endostar
    • Drug: DDP
  • Active Comparator: concurrent chemoradiotherapy

    Drug: DDP

    DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles

    Radiation: IMRT

    IMRT:70-74Gy

    Intervention: Drug: DDP
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. patients of either gender and aged from 18 to 70 years old.
  2. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
  3. patients at stage III/IVb by UICC2010 staging.
  4. KPS ≥ 70 (Appendix I)
  5. patients with available MRI data of nasopharynx and measurable tumor lesions.
  6. patients did not receive any treatment before enrollment.
  7. patients with expected survival longer than 6 months.
  8. biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 folds of the upper limit of normal value.
  9. the informed content was obtained from every patient.
  10. patients with effective follow-up.

Exclusion Criteria:

  1. those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
  2. those received treatments before enrollment.
  3. pregnant or lactating women and reproductive women without contraception.
  4. those who were undergoing other drug trials.
  5. those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
  6. those who could not be followed up at regular intervals.
  7. those who were treated with tumor targeting drugs.
  8. those who could not subject to MRI examination.
  9. those who could not meet the requirements of the prescribed dose.
  10. those with hemorrhagic tendency.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02907710
Other Study ID Numbers  ICMJE FirstGuangxiMU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party min kang, First Affiliated Hospital of Guangxi Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Guangxi Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: sheng ren wang, doctor First Affiliated Hospital of Guangxi Medical University
PRS Account First Affiliated Hospital of Guangxi Medical University
Verification Date September 2016

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