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NCT Number: NCT03086681

Endostar Combined With Concurrent Chemoradiotherapy For 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.

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Key information

Conditions

Cervical Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endostar

Drug

Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles

Other names: recombinant human endostatin

DDP

Drug

DDP: 40mg /m2，per week, for 5 cycles

Other names: cisplatin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yong Zhang,MD

Other

Registry information

Official study title

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

Acronym: ECWHCCFLACC

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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