NCT01733589

Brief Summary

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

November 2, 2012

Last Update Submit

July 11, 2017

Conditions

Stage III Non-small-Cell Lung Cancer

Keywords

Recombinant human endostatinNon-small-Cell Lung Cancerchemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    from beginning treatment to progressive disease or the last follow-up

    2-year

Secondary Outcomes (3)

  • Response rate

    1 month

  • overall survival

    5 years

  • treatment related toxicities

    3 months

Study Arms (1)

Recombinant Human Endostatin

EXPERIMENTAL

All patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60\~66Gy in 30\~33 fractions for 6\~7 weeks.

Drug: Recombinant human endostatinDrug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cyclesDrug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cyclesOther: laboratory biomarker analysisOther: CT perfusion imaging

Interventions

Recombinant human endostatinDRUG

Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.

Recombinant Human Endostatin
Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cyclesDRUG
Recombinant Human Endostatin
cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cyclesDRUG
Recombinant Human Endostatin
laboratory biomarker analysisOTHER
Recombinant Human Endostatin
CT perfusion imagingOTHER
Recombinant Human Endostatin

Eligibility Criteria

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

You may qualify if:

  • untreated histologic or cytologic of NSCLC verified
  • inoperable stage IIIA or IIIB NSCLC
  • measurable disease by RECIST
  • \~70 years of age
  • an ECOG PS of 0 to 1
  • absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
  • serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
  • bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
  • forced vital capacity in 1 second (FEV1) higher than 0.8 L
  • CB6 is normal
  • Written informed consent

You may not qualify if:

  • a history of other malignant diseases
  • any contraindications for chemoradiotherapy
  • distant metastasis
  • malignant pleural and/or pericardial effusion
  • pregnant or nursing
  • preexisting bleeding diatheses or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

EndostatinsEtoposideCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological FactorsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Ming Chen, M.D.

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 27, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

CN(1)