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Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma (ECWHCCFLACC)

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ClinicalTrials.gov Identifier: NCT03086681
Recruitment Status : Unknown
Verified March 2017 by Yong Zhang,MD, First Affiliated Hospital of Guangxi Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Yong Zhang,MD, First Affiliated Hospital of Guangxi Medical University

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 22, 2017
Last Update Posted Date March 22, 2017
Estimated Study Start Date  ICMJE March 2017
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
short-time effect [ Time Frame: 3 months ]
3 months after treatment, the subjects go into observation period. MRI/CT will be used for evaluating the carcinoma status.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • Overall Survival [ Time Frame: 3 years,5 years ]
    OS was calculated from the date of entry into the study to the date of death or the last follow-up visit.
  • Progression-Free Survival [ Time Frame: 3 years,5 years ]
    PFS was calculated from the date of entry into the study to the date of first physical or radio-graphic evidence of disease progression, death or the last follow-up visit.
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 Locally Advanced Cervical Carcinoma
Official Title  ICMJE A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma
Brief Summary A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. Patients were randomly divided into two groups, with 60 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 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 Locally advanced cervical carcinoma with high efficacy and low toxicity.
Detailed Description This study was a multicenter, 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. Nine medical centers participated in this study and 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. These patients were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 45-50Gy, DDP 40mg/m2, per week for 5cycles, Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles) and concurrent chemoradiotherapy group ( IMRT 45-50Gy, DDP 40mg/m2, per week, for 5cycles). 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cervical Carcinoma
Intervention  ICMJE
  • Drug: Endostar
    Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles
    Other Name: recombinant human endostatin
  • Drug: DDP
    DDP: 40mg /m2,per week, for 5 cycles
    Other Name: cisplatin
Study Arms  ICMJE
  • Experimental: concurrent chemoradiotherapy + endostar
    4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy
    Interventions:
    • Drug: Endostar
    • Drug: DDP
  • Active Comparator: concurrent chemoradiotherapy
    5 cycles of DDP concurrent with radiotherapy
    Intervention: Drug: DDP
Publications * Not Provided

*   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: March 16, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients of either gender and aged from 18 to 65 years old.
  • patients with histologically confirmed cervical carcinoma.
  • patients at stage Ib, IIa2, IIb-IVa by FIGO 2009 staging.
  • KPS ≥ 70 (Appendix I)
  • patients with available MRI or CT data of cervical and measurable tumor lesions.
  • patients did not receive any treatment before enrollment.
  • patients with expected survival longer than 6 months.
  • biochemical indexes: WBC > 4,000/mm3, and blood platelet ≥ 100,000 mm3; PT≤UNL; levels of indicators for hepatic and renal function was 1.5 folds of the upper limit of normal value.
  • the informed content was obtained from every patient.
  • patients with effective follow-up.

Exclusion Criteria:

  • those with malignant tumors other than cervical carcinoma.
  • those received treatments before enrollmment.
  • lactating women and Pregnant woman.
  • those who were undergoing other drug trials.
  • those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
  • those who were treated with tumor targeting drugs.
  • those who could not subject to MRI or CT examination.
  • those who could not meet the requirements of the prescribed dose.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 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 NCT03086681
Other Study ID Numbers  ICMJE FirstGuangxiMU-2016-062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yong Zhang,MD, First Affiliated Hospital of Guangxi Medical University
Study Sponsor  ICMJE Yong Zhang,MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yong Zhang, MD First Affiliated Hospital of Guangxi Medical University
PRS Account First Affiliated Hospital of Guangxi Medical University
Verification Date March 2017

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