Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma

Cervical Carcinoma Clinical Trial

— ECWHCCFLACC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03086681
• Other study ID #: FirstGuangxiMU-2016-062
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 16, 2017
• Last updated: March 16, 2017
• Start date: March 2017
• Est. completion date: February 2020

Study information

• Verified date: March 2017
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: Yong Zhang, MD
• Phone: 0086-13607884001
• Email: zhangyonggx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma

Intervention

Drug:
• Endostar
Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles
• DDP
DDP: 40mg /m2,per week, for 5 cycles

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Yong Zhang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short-time effect	3 months after treatment, the subjects go into observation period. MRI/CT will be used for evaluating the carcinoma status.	3 months
Secondary	Overall Survival	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
Secondary	Progression-Free Survival	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

External Links

•   A randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stages IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes
•   A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer
•   Antiangiogenic agents and their promising potential in combined therapy
•   Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma.
•   Clinical efficacy of modified preoperative neoadjuvant chemotherapy in the treatment of locally advanced (stage IB2 to IIB) cervical cancer: randomized study
•   Clinical potential of bevacizumab in the treatment of metastatic and locally advanced cervical cancer
•   Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 2000;18:1
•   Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer
•   Function of endogenous inhibitors of angiogenesis as endothelium specific tumor suppressors
•   Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262.
•   Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa
•   Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: a phase III randomized trial of the Gynecologic Oncology Group
•   Modern radiotherapy and cervical cancer.
•   Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung caner
•   Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer.
•   Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med 1999;340:1137-1143.
•   Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cerix: a gynecologic oncology group study
•   Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study
•   Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials
•   Role of angiogenesis in tumor growth and metastasis
•   Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis