Clinical trial · Interventional
Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma
Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DDP | Drug | Cisplatin | ALIAS |
| endostar | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- endostar + IMRT
- interventionNames
- Drug: endostar
- Radiation: IMRT
- type
- ACTIVE_COMPARATOR
- label
- DDP + IMRT
- interventionNames
- Drug: DDP
- Radiation: IMRT
Primary outcomes (1)
- measure
- 5-year Overall Survival
- timeFrame
- 6 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded. 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.
References
Publications (8)
- BACKGROUNDLee 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
- BACKGROUNDYeh 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
- BACKGROUNDYi 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
- BACKGROUNDLee 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
- BACKGROUNDPow 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
- BACKGROUNDChan 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.