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

March 16, 2017 updated by: Yong Zhang,MD

A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Fang Wu, MD
  • Phone Number: 0086-13978880156
  • Email: 96160f@163.com

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • 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

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • recombinant human endostatin
Drug: DDP
DDP: 40mg /m2，per week, for 5 cycles
Other Names:
  • cisplatin
ACTIVE_COMPARATOR: concurrent chemoradiotherapy
5 cycles of DDP concurrent with radiotherapy
Drug: DDP
DDP: 40mg /m2，per week, for 5 cycles
Other Names:
  • cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years,5 years
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.
3 years,5 years

Collaborators and Investigators

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

Sponsor

Yong Zhang,MD

Investigators

  • Study Chair: Yong Zhang, MD, First Affiliated Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ANTICIPATED)

March 1, 2017

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (ACTUAL)

March 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstGuangxiMU-2016-062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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