Clinical trial · Interventional
Endostar for Locally Recurrent Nasopharyngeal Carcinoma
A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients
NCT02636231CI-TRIAL-00049828unknownPhase 2ClinicalTrials.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)
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
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 |
|---|---|---|---|
| Endostatins | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IMRT and concurrent Endostar
- description
- IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. IMRT is to give GTV 60Gy in 27 fractions.
- interventionNames
- Drug: Endostatins
- Radiation: IMRT
- type
- EXPERIMENTAL
- label
- IMRT alone
- description
- IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.
- interventionNames
- Radiation: IMRT
Primary outcomes (1)
- measure
- Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma; 2. No evidence of distant metastasis 3. More than 1 year from the end of the first course of radiotherapy 4. Male, or female not in the phase of lactating or pregnancy 5. ECOG 0-2 6. Aged 18-70 years old 7. WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L 8. Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits 9. Written informed consort signed Exclusion Criteria: 1. Only regionally recurrence 2. Evidence of distant metastasis 3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted 4. Severe, active co-morbidity 5. Prior anti-tumor treatment after diagnosis of local recurrence 6. MRI was not performed 3 months after the first course of radiotherapy 7. Abnormal function of heart, brain and lungs, etc 8. Lactation or pregnancy 9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
References
Publications (5)
- RESULTHan F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29. PMID 22209574
- RESULTZhang K, Yang S, Zhu Y, Mo A, Zhang D, Liu L. Protection against acute radiation-induced lung injury: a novel role for the anti-angiogenic agent Endostar. Mol Med Rep. 2012 Aug;6(2):309-15. doi: 10.3892/mmr.2012.903. Epub 2012 May 4. PMID 22562140
- RESULTPeng F, Xu Z, Wang J, Chen Y, Li Q, Zuo Y, Chen J, Hu X, Zhou Q, Wang Y, Ma H, Bao Y, Chen M. Recombinant human endostatin normalizes tumor vasculature and enhances radiation response in xenografted human nasopharyngeal carcinoma models. PLoS One. 2012;7(4):e34646. doi: 10.1371/journal.pone.0034646. Epub 2012 Apr 9. PMID 22496834
- RESULTTong RT, Boucher Y, Kozin SV, Winkler F, Hicklin DJ, Jain RK. Vascular normalization by vascular endothelial growth factor receptor 2 blockade induces a pressure gradient across the vasculature and improves drug penetration in tumors. Cancer Res. 2004 Jun 1;64(11):3731-6. doi: 10.1158/0008-5472.CAN-04-0074. PMID 15172975
- RESULTTian YM, Guan Y, Xiao WW, Zeng L, Liu S, Lu TX, Zhao C, Han F. Long-term survival and late complications in intensity-modulated radiotherapy of locally recurrent T1 to T2 nasopharyngeal carcinoma. Head Neck. 2016 Feb;38(2):225-31. doi: 10.1002/hed.23880. Epub 2015 May 27. PMID 25244494