Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02907710
• Other study ID #: FirstGuangxiMU
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 13, 2016
• Last updated: September 15, 2016
• Start date: October 2016
• Est. completion date: November 2019

Study information

• Verified date: September 2016
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: min kang, doctor
• Phone: 0086-0771-5356509
• Email: km1019[@]163.com
• Is FDA regulated: No
• Health authority: China:Guangxi Medical University
• Study type: Interventional

Clinical Trial Summary

A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. Patients were randomly divided into two groups, with 150 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 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. The investigators data may provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with high efficacy and low toxicity.

Description:

This study was a multicenter, prospective, 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. Five medical centers participated in this study and 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and concurrent chemoradiotherapy 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. patients of either gender and aged from 18 to 70 years old.

2. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.

3. patients at stage III/IVb by UICC2010 staging.

4. KPS = 70 (Appendix I)

5. patients with available MRI data of nasopharynx and measurable tumor lesions.

6. patients did not receive any treatment before enrollment.

7. patients with expected survival longer than 6 months.

8. 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.

9. the informed content was obtained from every patient.

10. patients with effective follow-up.

Exclusion Criteria:

1. those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.

2. those received treatments before enrollment.

3. pregnant or lactating women and reproductive women without contraception.

4. those who were undergoing other drug trials.

5. those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.

6. those who could not be followed up at regular intervals.

7. those who were treated with tumor targeting drugs.

8. those who could not subject to MRI examination.

9. those who could not meet the requirements of the prescribed dose.

10. those with hemorrhagic tendency.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Endostar
intravenous infusion
• DDP

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

Druzgal CH, Chen Z, Yeh NT, Thomas GR, Ondrey FG, Duffey DC, Vilela RJ, Ende K, McCullagh L, Rudy SF, Muir C, Herscher LL, Morris JC, Albert PS, Van Waes C. A pilot study of longitudinal serum cytokine and angiogenesis factor levels as markers of therapeu — View Citation

Huang X, Wong MK, Zhao Q, Zhu Z, Wang KZ, Huang N, Ye C, Gorelik E, Li M. Soluble recombinant endostatin purified from Escherichia coli: antiangiogenic activity and antitumor effect. Cancer Res. 2001 Jan 15;61(2):478-81. Erratum in: Cancer Res 2001 Aug 1; — View Citation

Krishna SM, James S, Balaram P. Expression of VEGF as prognosticator in primary nasopharyngeal cancer and its relation to EBV status. Virus Res. 2006 Jan;115(1):85-90. Epub 2005 Sep 1. — View Citation

Kyzas PA, Cunha IW, Ioannidis JP. Prognostic significance of vascular endothelial growth factor immunohistochemical expression in head and neck squamous cell carcinoma: a meta-analysis. Clin Cancer Res. 2005 Feb 15;11(4):1434-40. — View 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. — View Citation

Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase I — View Citation

Qian CN, Zhang CQ, Guo X, Hong MH, Cao SM, Mai WY, Min HQ, Zeng YX. Elevation of serum vascular endothelial growth factor in male patients with metastatic nasopharyngeal carcinoma. Cancer. 2000 Jan 15;88(2):255-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year Progression Free Survival	The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar,including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy,and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.	3 years	Yes
Secondary	5-year Overall Survival	The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar,including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy,and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.	5 years	Yes