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Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostatins

IMRT

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Endostar, IMRT, recurrent, NPC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
No evidence of distant metastasis
More than 1 year from the end of the first course of radiotherapy
Male, or female not in the phase of lactating or pregnancy
ECOG 0-2
Aged 18-70 years old
WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
Written informed consort signed

Exclusion Criteria:

Only regionally recurrence
Evidence of distant metastasis
Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
Severe, active co-morbidity
Prior anti-tumor treatment after diagnosis of local recurrence
MRI was not performed 3 months after the first course of radiotherapy
Abnormal function of heart, brain and lungs, etc
Lactation or pregnancy
Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IMRT and concurrent Endostar

IMRT alone

Arm 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.

IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.

Outcomes

Primary Outcome Measures

Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

Secondary Outcome Measures

Number of participants with severe acute toxicities as assessed by CTCAE v3.0

Overall survival

Full Information

NCT ID

NCT02636231

First Posted

February 27, 2015

Last Updated

January 31, 2021

Sponsor

Sun Yat-sen University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02636231

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (Actual)

Primary Completion Date

March 2020 (Actual)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Endostar, IMRT, recurrent, NPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT and concurrent Endostar

Arm Type

Active Comparator

Arm Description

Arm Title

IMRT alone

Arm Type

Experimental

Arm Description

IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.

Intervention Type

Drug

Intervention Name(s)

Endostatins

Other Intervention Name(s)

Endostar

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

IMRT is to give GTV 60Gy in 27 fractions.

Primary Outcome Measure Information:

Title

Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

Time Frame

From 3 months after the end of IMRT to 1 year after the end of IMRT

Secondary Outcome Measure Information:

Title

Number of participants with severe acute toxicities as assessed by CTCAE v3.0

Time Frame

From the beginning of IMRT to 3 months after the end of IMRT

Title

Overall survival

Time Frame

From the beginning the IMRT to 3 year after the end of IMRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma; No evidence of distant metastasis More than 1 year from the end of the first course of radiotherapy Male, or female not in the phase of lactating or pregnancy ECOG 0-2 Aged 18-70 years old WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits Written informed consort signed Exclusion Criteria: Only regionally recurrence Evidence of distant metastasis Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted Severe, active co-morbidity Prior anti-tumor treatment after diagnosis of local recurrence MRI was not performed 3 months after the first course of radiotherapy Abnormal function of heart, brain and lungs, etc Lactation or pregnancy Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Han, M.D., Ph.D.

Organizational Affiliation

China: Ethics Committee

Official's Role

Principal Investigator

Facility Information:

Facility Name

First People's Hospital of Foshan

City

Foshan

State/Province

Guangdong

ZIP/Postal Code

528000

Country

China

Facility Name

Cancer Center of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Name

The First Affiliated Hospital of Clinical Medicine of G.D.P.U.

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

The Affiliated GanZhou Hospital of NanChang University

City

Ganzhou

State/Province

Jiangxi

ZIP/Postal Code

341000

Country

China

Facility Name

The First Hospital of Gannan Medical University

City

GanZhou

State/Province

Jiangxi

ZIP/Postal Code

341000

Country

China

Facility Name

Second Affiliated Hospital of Nanchang University

City

NanChang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

JiangXi Province Tumor Hospital

City

NanChang

State/Province

Jiangxi

ZIP/Postal Code

330029

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22209574

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.

Results Reference

result

PubMed Identifier

22562140

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.

Results Reference

result

PubMed Identifier

22496834

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.

Results Reference

result

PubMed Identifier

15172975

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.

Results Reference

result

PubMed Identifier

25244494

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.

Results Reference

result

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Endostar for Locally Recurrent Nasopharyngeal Carcinoma

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