ECWHCCFLACC: Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma

Sponsor

Yong Zhang,MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03086681

Collaborator

(none)

120

Enrollment

Location

Arms

35.1

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

short-time effect [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

Overall Survival [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.