Clinical trial · Interventional
Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
NCT02907710CI-TRIAL-00023932unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 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
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DDP | Drug | Cisplatin | ALIAS |
| Endostar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- concurrent chemoradiotherapy + endostar
- description
- 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
- interventionNames
- Drug: Endostar
- Drug: DDP
- type
- ACTIVE_COMPARATOR
- label
- concurrent chemoradiotherapy
- description
- Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy
- interventionNames
- Drug: DDP
Primary outcomes (1)
- measure
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/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.
References
Publications (7)
- RESULTLee 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
- RESULTLee 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
- RESULTKyzas 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
- RESULTQian 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
- RESULTKrishna 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
- RESULTDruzgal 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