Clinical trial NCT02636231: Endostar for Locally Recurrent Nasopharyngeal Carcinoma
Official title: A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Endostar
IMRT
recurrent
NPC
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: JiangXi Province Tumor Hospital
name: The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
name: Second Affiliated Hospital of Nanchang University
name: First People's Hospital of Foshan
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: The Affiliated Ganzhou Hospital of Nanchang University
name: First Affiliated Hospital of Gannan Medical University
First posted: 2015-12-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
timeFrame: From 3 months after the end of IMRT to 1 year after the end of IMRT
Secondary outcomes:
measure: Number of participants with severe acute toxicities as assessed by CTCAE v3.0
timeFrame: From the beginning of IMRT to 3 months after the end of IMRT
measure: Overall survival
timeFrame: From the beginning the IMRT to 3 year after the end of IMRT
Other outcomes:
Locations:
city: Foshan
country: China
facility: First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Ganzhou
country: China
facility: The Affiliated GanZhou Hospital of NanChang University
state: Jiangxi
city: GanZhou
country: China
facility: The First Hospital of Gannan Medical University
state: Jiangxi
city: NanChang
country: China
facility: Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: NanChang
country: China
facility: JiangXi Province Tumor Hospital
state: Jiangxi
Study officials:
affiliation: China: Ethics Committee
name: Fei Han, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.
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.
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(4):e34646. doi: 10.1371/journal.pone.0034646. Epub 2012 Apr 9.
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 1;64(11):3731-6. doi: 10.1158/0008-5472.CAN-04-0074.
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. Epub 2015 May 27.