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Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

Primary Purpose

Stage III Non-small-Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant human endostatin
Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles
cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles
laboratory biomarker analysis
CT perfusion imaging
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Non-small-Cell Lung Cancer focused on measuring Recombinant human endostatin, Non-small-Cell Lung Cancer, chemoradiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • untreated histologic or cytologic of NSCLC verified
  • inoperable stage IIIA or IIIB NSCLC
  • measurable disease by RECIST
  • 18~70 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recombinant Human Endostatin

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response rate
complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)
overall survival
from date of beginning treatment until date of death
treatment related toxicities
radiation-induced esophagitis; radiation-induced pneumonia

Full Information

First Posted
November 2, 2012
Last Updated
July 11, 2017
Sponsor
Zhejiang Cancer Hospital
Collaborators
Chinese Academy of Medical Sciences, Fudan University, Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Shandong Cancer Hospital and Institute, Jiangsu Cancer Institute & Hospital, Fujian Cancer Hospital, The First People's Hospital of Lianyungang
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1. Study Identification

Unique Protocol Identification Number
NCT01733589
Brief Title
Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
Official Title
Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
Chinese Academy of Medical Sciences, Fudan University, Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Shandong Cancer Hospital and Institute, Jiangsu Cancer Institute & Hospital, Fujian Cancer Hospital, The First People's Hospital of Lianyungang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Primary Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC). Secondary Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients. Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Non-small-Cell Lung Cancer
Keywords
Recombinant human endostatin, Non-small-Cell Lung Cancer, chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Human Endostatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Recombinant human endostatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
CT perfusion imaging
Primary Outcome Measure Information:
Title
progression-free survival
Description
from beginning treatment to progressive disease or the last follow-up
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Response rate
Description
complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)
Time Frame
1 month
Title
overall survival
Description
from date of beginning treatment until date of death
Time Frame
5 years
Title
treatment related toxicities
Description
radiation-induced esophagitis; radiation-induced pneumonia
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: untreated histologic or cytologic of NSCLC verified inoperable stage IIIA or IIIB NSCLC measurable disease by RECIST 18~70 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Chen, M.D.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

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Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

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