Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02636231
• Other study ID #: NPC201501
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.

The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Endostatins
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.

Radiation:
• IMRT
IMRT is to give GTV 60Gy in 27 fractions.

Locations

Country	Name	City	State
China	First People's Hospital of Foshan	Foshan	Guangdong
China	The Affiliated GanZhou Hospital of NanChang University	Ganzhou	Jiangxi
China	The First Hospital of Gannan Medical University	GanZhou	Jiangxi
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Clinical Medicine of G.D.P.U.	Guangzhou	Guangdong
China	JiangXi Province Tumor Hospital	NanChang	Jiangxi
China	Second Affiliated Hospital of Nanchang University	NanChang	Jiangxi

Sponsors (8)

Lead Sponsor	Collaborator
Sun Yat-sen University	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, First People's Hospital of Foshan, JiangXi Province Tumor Hospital, Second Affiliated Hospital of Nanchang University, The Affiliated Ganzhou Hospital of Nanchang University, The First Affiliated Hospital of Clinical Medicine of G.D.P.U., The First Hospital of Gannan Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Han 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 Radio — View Citation

Peng 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( — View Citation

Tian 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. — View Citation

Tong 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 — View Citation

Zhang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema		From 3 months after the end of IMRT to 1 year after the end of IMRT
Secondary	Number of participants with severe acute toxicities as assessed by CTCAE v3.0		From the beginning of IMRT to 3 months after the end of IMRT
Secondary	Overall survival		From the beginning the IMRT to 3 year after the end of IMRT