Clinical trial NCT03086681: Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma
Official title: A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Carcinoma
Keywords: Cervical carcinoma
endostar
concurrent chemoradiotherapy
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: short-time effect
timeFrame: 3 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years,5 years
measure: Progression-Free Survival
timeFrame: 3 years,5 years
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Yong Zhang, MD
role: STUDY_CHAIR
References: