NCT02636231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

February 27, 2015

Last Update Submit

January 31, 2021

Conditions

Nasopharyngeal Carcinoma

Keywords

EndostarIMRTrecurrentNPC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Overall survival

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

Study Arms (2)

IMRT and concurrent Endostar

ACTIVE COMPARATOR

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.

Drug: EndostatinsRadiation: IMRT

IMRT alone

EXPERIMENTAL

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

Radiation: IMRT

Interventions

EndostatinsDRUG

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

Also known as: Endostar
IMRT and concurrent Endostar
IMRTRADIATION

IMRT is to give GTV 60Gy in 27 fractions.

IMRT aloneIMRT and concurrent Endostar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

The Affiliated GanZhou Hospital of NanChang University

Ganzhou, Jiangxi, 341000, China

Location

The First Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China

Location

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

JiangXi Province Tumor Hospital

Nanchang, Jiangxi, 330029, China

Location

Related 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 Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.

    PMID: 22209574RESULT

  • 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.

    PMID: 22562140RESULT

  • 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.

    PMID: 22496834RESULT

  • 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.

    PMID: 15172975RESULT

  • 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.

    PMID: 25244494RESULT

MeSH Terms

Conditions

Nasopharyngeal CarcinomaRecurrence

Interventions

Endostatinsendostar protein

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Fei Han, M.D., Ph.D.

    China: Ethics Committee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2015

First Posted

December 21, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2020

Study Completion

December 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01

Locations

CN(8)