Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

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.

Condition or disease Intervention/treatment Phase
Cervical Carcinoma Drug: Endostar Drug: DDP Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: concurrent chemoradiotherapy + endostar
4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy
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

Active Comparator: concurrent chemoradiotherapy
5 cycles of DDP concurrent with radiotherapy
Drug: DDP
DDP: 40mg /m2,per week, for 5 cycles
Other Name: cisplatin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03086681


Contacts
Layout table for location contacts
Contact: Yong Zhang, MD 0086-13607884001 zhangyonggx@163.com
Contact: Fang Wu, MD 0086-13978880156 96160f@163.com

Locations
Layout table for location information
China, Guangxi
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Contact: Yong Zhang, M.D.    0086-13607884001    zhangyonggx@163.com   
Contact: Fang Wu, M.D.         
Sub-Investigator: Jian Li, M.D.         
Sub-Investigator: Hemin Lu, M.D.         
Sub-Investigator: Haixin Huang, Master         
Sub-Investigator: Zhanxiong Luo, Master         
Sub-Investigator: Meilian Liu, Master         
Sub-Investigator: Gaojuan Lin, Master         
Sub-Investigator: Sihui Liao, bachelor         
Sub-Investigator: Hongqian Wang, bachelor         
Sponsors and Collaborators
Yong Zhang,MD
Investigators
Layout table for investigator information
Study Chair: Yong Zhang, MD First Affiliated Hospital of Guangxi Medical University
Additional Information:

Layout table for additonal information
Responsible Party: Yong Zhang,MD, MD, First Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT03086681    
Other Study ID Numbers: FirstGuangxiMU-2016-062
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yong Zhang,MD, First Affiliated Hospital of Guangxi Medical University:
Cervical carcinoma
endostar
concurrent chemoradiotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Endostar protein
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors