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

Primary Purpose

Cervical Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Endostar

DDP

About this trial

This is an interventional treatment trial for Cervical Carcinoma focused on measuring Cervical carcinoma, endostar, concurrent chemoradiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

First Affiliated Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

concurrent chemoradiotherapy + endostar

concurrent chemoradiotherapy

Arm Description

4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy

5 cycles of DDP concurrent with radiotherapy

Outcomes

Primary Outcome Measures

short-time effect

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

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

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.

Full Information

NCT ID

NCT03086681

First Posted

March 16, 2017

Last Updated

March 16, 2017

Sponsor

Yong Zhang,MD

1. Study Identification

Unique Protocol Identification Number

NCT03086681

Brief Title

Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2017 (Anticipated)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yong Zhang,MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Carcinoma

Keywords

Cervical carcinoma, endostar, concurrent chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

concurrent chemoradiotherapy + endostar

Arm Type

Experimental

Arm Description

4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy

Arm Title

concurrent chemoradiotherapy

Arm Type

Active Comparator

Arm Description

5 cycles of DDP concurrent with radiotherapy

Intervention Type

Drug

Intervention Name(s)

Endostar

Other Intervention Name(s)

recombinant human endostatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

DDP

Other Intervention Name(s)

cisplatin

Intervention Description

DDP: 40mg /m2，per week, for 5 cycles

Primary Outcome Measure Information:

Title

short-time effect

Description

3 months after treatment, the subjects go into observation period. MRI/CT will be used for evaluating the carcinoma status.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

OS was calculated from the date of entry into the study to the date of death or the last follow-up visit.

Time Frame

3 years,5 years

Title

Progression-Free Survival

Description

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.

Time Frame

3 years,5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Zhang, MD

Phone

0086-13607884001

zhangyonggx@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Fang Wu, MD

Phone

0086-13978880156

96160f@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Zhang, MD

Organizational Affiliation

First Affiliated Hospital of Guangxi Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

First Affiliated Hospital of Guangxi Medical University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong Zhang, M.D.

Phone

0086-13607884001

zhangyonggx@163.com

First Name & Middle Initial & Last Name & Degree

Fang Wu, M.D.

First Name & Middle Initial & Last Name & Degree

Jian Li, M.D.

First Name & Middle Initial & Last Name & Degree

Hemin Lu, M.D.

First Name & Middle Initial & Last Name & Degree

Haixin Huang, Master

First Name & Middle Initial & Last Name & Degree

Zhanxiong Luo, Master

First Name & Middle Initial & Last Name & Degree

Meilian Liu, Master

First Name & Middle Initial & Last Name & Degree

Gaojuan Lin, Master

First Name & Middle Initial & Last Name & Degree

Sihui Liao, bachelor

First Name & Middle Initial & Last Name & Degree

Hongqian Wang, bachelor

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/25651787

Description

Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262.

URL

https://www.ncbi.nlm.nih.gov/pubmed/24552320

Description

Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa

URL

http://www.ncbi.nlm.nih.gov/pubmed/10764420

Description

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

URL

http://www.ncbi.nlm.nih.gov/pubmed/10202164

Description

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.

URL

http://www.ncbi.nlm.nih.gov/pubmed/10202164

Description

Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer.

URL

https://www.ncbi.nlm.nih.gov/pubmed/10202166

Description

Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma.

URL

http://www.ncbi.nlm.nih.gov/pubmed/12109823

Description

Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer

URL

https://www.ncbi.nlm.nih.gov/pubmed/10334517

Description

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

URL

https://www.ncbi.nlm.nih.gov/pubmed/11564482

Description

Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis

URL

https://www.ncbi.nlm.nih.gov/pubmed/18606439

Description

Clinical efficacy of modified preoperative neoadjuvant chemotherapy in the treatment of locally advanced (stage IB2 to IIB) cervical cancer: randomized study

URL

https://www.ncbi.nlm.nih.gov/pubmed/19001332

Description

Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials

URL

https://www.ncbi.nlm.nih.gov/pubmed/21053528

Description

Modern radiotherapy and cervical cancer.

URL

https://www.ncbi.nlm.nih.gov/pubmed/16376417

Description

Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study

URL

https://www.ncbi.nlm.nih.gov/pubmed/25827291

Description

A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer

URL

https://www.ncbi.nlm.nih.gov/pubmed/12516034

Description

Role of angiogenesis in tumor growth and metastasis

URL

http://www.ncbi.nlm.nih.gov/pubmed/11418313

Description

Antiangiogenic agents and their promising potential in combined therapy

URL

http://www.ncbi.nlm.nih.gov/pubmed/15710885

Description

Function of endogenous inhibitors of angiogenesis as endothelium specific tumor suppressors

URL

http://www.ncbi.nlm.nih.gov/pubmed/17167137

Description

Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung caner

URL

http://www.ncbi.nlm.nih.gov/pubmed/19139430

Description

Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cerix: a gynecologic oncology group study

URL

http://www.ncbi.nlm.nih.gov/pubmed/25842084

Description

Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: a phase III randomized trial of the Gynecologic Oncology Group

URL

http://www.ncbi.nlm.nih.gov/pubmed/26418895

Description

Clinical potential of bevacizumab in the treatment of metastatic and locally advanced cervical cancer

Learn more about this trial

Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma

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