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Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
radiotherapy combined with EP
radiotherapy / EP combined with recombinant human endostatin
Sponsored by
Simcere Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Radiotherapy, rh-endostatin, chemotherapy, NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
  2. Patients with ages of 18~70 years, general condition ECOG performance scale (PS)≤ 1, weight loss <10% during last 6 months;
  3. CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.)
  4. No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value;
  5. Patients could understand the circumstances of this study and those who have signed the informed consent form;

Exclusion Criteria:

  1. Pregnant or lactating women; women of child-bearing age without contraception;
  2. Acute infection or other serious underlying diseases;
  3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
  4. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
  5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
  6. Patients who are allergic to E. coli preparation;
  7. Patients who are unsuitable to participate in this trial determined by the researchers.

Sites / Locations

  • Daping Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

radiotherapy combined with EP

adiotherapy / EP /recombinant human endostatin

Arm Description

the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.

recombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg,d1-14, intravenous injection.

Outcomes

Primary Outcome Measures

overall survival (OS)

Secondary Outcome Measures

quality of life
objective response rate (ORR)
disease control rate (DCR)
progression-free survival (PFS)

Full Information

First Posted
September 27, 2010
Last Updated
September 28, 2010
Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01211002
Brief Title
Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title
The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Radiotherapy, rh-endostatin, chemotherapy, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy combined with EP
Arm Type
Active Comparator
Arm Description
the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
Arm Title
adiotherapy / EP /recombinant human endostatin
Arm Type
Experimental
Arm Description
recombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg,d1-14, intravenous injection.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy combined with EP
Intervention Description
Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
Intervention Type
Drug
Intervention Name(s)
radiotherapy / EP combined with recombinant human endostatin
Intervention Description
Anti-vascular targeting therapy The number of courses is 3 ~ 4 and each course last for 28 days. Recombinant human endostatin(Endostar):15mg,d1-14, intravenous injection.
Primary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
2 years
Title
objective response rate (ORR)
Time Frame
1 years
Title
disease control rate (DCR)
Time Frame
1 year
Title
progression-free survival (PFS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC; Patients with ages of 18~70 years, general condition ECOG performance scale (PS)≤ 1, weight loss <10% during last 6 months; CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.) No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value; Patients could understand the circumstances of this study and those who have signed the informed consent form; Exclusion Criteria: Pregnant or lactating women; women of child-bearing age without contraception; Acute infection or other serious underlying diseases; Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent; Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial; Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration); Patients who are allergic to E. coli preparation; Patients who are unsuitable to participate in this trial determined by the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhou Yang, M.D.
Email
yangzhenzhou@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhenzhou yang, M.D.
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Daping Hospital
City
Chongqin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhenzhou yang, M.D.
Email
yangzhenzhou@sohu.com
First Name & Middle Initial & Last Name & Degree
zhenzhou yang, M.D.

12. IPD Sharing Statement

Learn more about this trial

Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)

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