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

NCT02237924 | Completed Phase 2 DMC

• 1 other identifier: S201413__19
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; endostar; IMRT; chemoradiation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 years

Secondary Outcomes (1)

• 3-year Progression Free Survival

  4 years

Study Arms (2)

endostar + IMRT

EXPERIMENTAL

Drug: endostar; Radiation: IMRT

DDP + IMRT

ACTIVE COMPARATOR

Drug: DDP; Radiation: IMRT

Interventions

endostar DRUG

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

endostar + IMRT

DDP DRUG

DDP:100mg/m2 for 2-3 cycles

DDP + IMRT

IMRT RADIATION

IMRT:70-74Gy for 2-3 cycles

DDP + IMRT; endostar + IMRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• 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/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.

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 (8)

• 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 BACKGROUND

• 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.

  PMID: 15936544 BACKGROUND

• 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.

  PMID: 16542792 BACKGROUND

• 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.

  PMID: 22178121 BACKGROUND

• 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.

  PMID: 17145528 BACKGROUND

• 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.

  PMID: 11956263 BACKGROUND

• 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.

  PMID: 16192584 BACKGROUND

• 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.

  PMID: 19459845 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

endostar protein

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

Study Officials

• Sheng ren Wang, doctor

  First Affiliated Hospital of Guangxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 9, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

CN (1)