Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT02907710 | Unknown Phase 3

• 1 other identifier: FirstGuangxiMU
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; endostar; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 5-year Overall Survival

  5 years

Study Arms (2)

concurrent chemoradiotherapy + endostar

EXPERIMENTAL

Drug: Endostar Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy

Drug: Endostar; Drug: DDP

concurrent chemoradiotherapy

ACTIVE COMPARATOR

Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy

Drug: DDP

Interventions

Endostar DRUG

intravenous infusion

Also known as: recombinant human endostatin

concurrent chemoradiotherapy + endostar

DDP DRUG

concurrent chemoradiotherapy; concurrent chemoradiotherapy + endostar

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/IVb by UICC2010 staging.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related Publications (7)

• 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.

  PMID: 15752890 RESULT

• 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 II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.

  PMID: 19564532 RESULT

• 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. doi: 10.1158/1078-0432.CCR-04-1870.

  PMID: 15746043 RESULT

• 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.

  PMID: 10640954 RESULT

• 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. doi: 10.1016/j.virusres.2005.07.010. Epub 2005 Sep 1.

  PMID: 16139912 RESULT

• 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 therapeutic response and survival in patients with head and neck squamous cell carcinoma. Head Neck. 2005 Sep;27(9):771-84. doi: 10.1002/hed.20246.

  PMID: 15920746 RESULT

• 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.

  PMID: 11212235 RESULT

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

endostar protein; Endostatins

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• sheng ren wang, doctor

  First Affiliated Hospital of Guangxi Medical University

  STUDY CHAIR

Central Study Contacts

min kang, doctor

CONTACT

0086-0771-5356509; km1019@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 20, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

CN (1)