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Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

endostar

DDP

IMRT

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring nasopharyngeal carcinoma, endostar, IMRT, chemoradiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patients of either gender and aged from 18 to 70 years old.
patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded.
KPS ≥ 70 (Appendix I)
patients with available MRI data of nasopharynx and measurable tumor lesions.
patients did not receive any treatment before enrollment.
patients with expected survival longer than 6 months.
biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 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 nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
those received treatments before enrollment.
pregnant or lactating women and reproductive women without contraception.
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 could not be followed up at regular intervals.
those who were treated with tumor targeting drugs.
those who could not subject to MRI examination.
those who could not meet the requirements of the prescribed dose.
those with hemorrhagic tendency.

Sites / Locations

The First Affiliated Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endostar + IMRT

DDP + IMRT

Arm Description

Outcomes

Primary Outcome Measures

5-year Overall Survival

The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ，including 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy，and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.

Secondary Outcome Measures

3-year Progression Free Survival

Full Information

NCT ID

NCT02237924

First Posted

September 9, 2014

Last Updated

January 30, 2022

Sponsor

First Affiliated Hospital of Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02237924

Brief Title

Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma

Official Title

Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2021 (Actual)

Study Completion Date

January 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Guangxi Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A total of 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60 patients in each group. One group was treated with intensity-modulated radiation therapy (IMRT) combined with Endostar and the other group was treated with IMRT combined with concurrent chemotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. Our data may provide an alternative option for the treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low toxicity.

Detailed Description

This study was a multicenter, open-label, 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 low-risk nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: IMRT combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy) and IMRT combined with concurrent chemotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). 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

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma, endostar, IMRT, chemoradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

endostar + IMRT

Arm Type

Experimental

Arm Title

DDP + IMRT

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

endostar

Intervention Description

Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy

Intervention Type

Drug

Intervention Name(s)

DDP

Intervention Description

DDP:100mg/m2 for 2-3 cycles

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

IMRT:70-74Gy for 2-3 cycles

Primary Outcome Measure Information:

Title

5-year Overall Survival

Description

Time Frame

6 years

Secondary Outcome Measure Information:

Title

3-year Progression Free Survival

Description

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients of either gender and aged from 18 to 70 years old. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma. patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded. KPS ≥ 70 (Appendix I) patients with available MRI data of nasopharynx and measurable tumor lesions. patients did not receive any treatment before enrollment. patients with expected survival longer than 6 months. biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 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 nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ. those received treatments before enrollment. pregnant or lactating women and reproductive women without contraception. 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 could not be followed up at regular intervals. those who were treated with tumor targeting drugs. those who could not subject to MRI examination. those who could not meet the requirements of the prescribed dose. those with hemorrhagic tendency.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheng ren Wang, doctor

Organizational Affiliation

First Affiliated Hospital of Guangxi Medical University

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital of Guangxi Medical University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

15752890

Citation

Lee AW, Sze WM, Au JS, Leung SF, Leung TW, Chua DT, Zee BC, Law SC, Teo PM, Tung SY, Kwong DL, Lau WH. Treatment results for nasopharyngeal carcinoma in the modern era: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2005 Mar 15;61(4):1107-16. doi: 10.1016/j.ijrobp.2004.07.702.

Results Reference

background

PubMed Identifier

15936544

Citation

Yeh SA, Tang Y, Lui CC, Huang YJ, Huang EY. Treatment outcomes and late complications of 849 patients with nasopharyngeal carcinoma treated with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):672-9. doi: 10.1016/j.ijrobp.2004.11.002.

Results Reference

background

PubMed Identifier

16542792

Citation

Yi JL, Gao L, Huang XD, Li SY, Luo JW, Cai WM, Xiao JP, Xu GZ. Nasopharyngeal carcinoma treated by radical radiotherapy alone: Ten-year experience of a single institution. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):161-8. doi: 10.1016/j.ijrobp.2005.12.003. Epub 2006 Mar 20.

Results Reference

background

PubMed Identifier

22178121

Citation

Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.

Results Reference

background

PubMed Identifier

17145528

Citation

Pow EH, Kwong DL, McMillan AS, Wong MC, Sham JS, Leung LH, Leung WK. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: initial report on a randomized controlled clinical trial. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):981-91. doi: 10.1016/j.ijrobp.2006.06.013.

Results Reference

background

PubMed Identifier

11956263

Citation

Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. doi: 10.1200/JCO.2002.08.149.

Results Reference

background

PubMed Identifier

16192584

Citation

Lee AW, Lau WH, Tung SY, Chua DT, Chappell R, Xu L, Siu L, Sze WM, Leung TW, Sham JS, Ngan RK, Law SC, Yau TK, Au JS, O'Sullivan B, Pang ES, O SK, Au GK, Lau JT; Hong Kong Nasopharyngeal Cancer Study Group. Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group. J Clin Oncol. 2005 Oct 1;23(28):6966-75. doi: 10.1200/JCO.2004.00.7542.

Results Reference

background

PubMed Identifier

19459845

Citation

Wen QL, Meng MB, Yang B, Tu LL, Jia L, Zhou L, Xu Y, Lu Y. Endostar, a recombined humanized endostatin, enhances the radioresponse for human nasopharyngeal carcinoma and human lung adenocarcinoma xenografts in mice. Cancer Sci. 2009 Aug;100(8):1510-9. doi: 10.1111/j.1349-7006.2009.01193.x. Epub 2009 May 21.

Results Reference

background

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Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma

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