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Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer (DP-EN-RT)

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostatin

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Stage III, Unresectable, Non-small cell lung cancer

Eligibility Criteria

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

Inclusion Criteria:

18 years of age
- untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
- weight loss of less than 10% in the past 6 months
- performance status (PS) of 0 to 1
- forced vital capacity in 1 second (FEV1) higher than 0.8 L
- measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- absolute neutrophil count (ANC) of ≥ 1500/μL
- hemoglobin ≥ 10 mg/dL
- platelet ≥ 100,000/μL
- serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
- calculated creatinine clearance (CrCl) of ≥ 60 ml/min
- bilirubin 1.5×ULN
- AST and ALT less than 2.5×ULN
- alkaline phosphatase less than 5×ULN.

Exclusion Criteria:

active infection
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
malnutrition (loss of ≥ 20% of the original body weight)
sensor or motor neuropathy > grade I
second primary malignancy, except for non-melanoma skin cancer
psychiatric illness or social situation that would preclude study compliance
pregnant or lactating women
preexisting bleeding diatheses or coagulopathy
Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway

Sites / Locations

Sun Yat-Sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostatin combine CCRT

Arm Description

7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Outcomes

Primary Outcome Measures

Response Rate (RR)

Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).

Secondary Outcome Measures

Full Information

NCT ID

NCT01218594

First Posted

June 1, 2010

Last Updated

September 17, 2012

Sponsor

Sun Yat-sen University

Collaborators

Affiliated Hospital of Guangdong Medical University, Fujian Province Tumor Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, The Affiliated Tumor Hospital of Guangxi Medical University, Zhejiang Cancer Hospital, Guangzhou General Hospital of Guangzhou Military Command, The 458 Hospital of Chinese PLA

1. Study Identification

Unique Protocol Identification Number

NCT01218594

Brief Title

Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

Acronym

DP-EN-RT

Official Title

Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination 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

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2015 (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

Yes

5. Study Description

Brief Summary

To 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).

Detailed Description

OBJECTIVES: Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT Secondary The progression-free survival (PFS) The overall survival(OS). The failed treatment modality. The toxicity of this regimen. OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy. Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks. Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.

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

Stage III, Unresectable, Non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endostatin combine CCRT

Arm Type

Experimental

Arm Description

7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Endostatin

Other Intervention Name(s)

Endostar

Intervention Description

7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Primary Outcome Measure Information:

Title

Response Rate (RR)

Description

Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).

Time Frame

4 weeks after CCRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC weight loss of less than 10% in the past 6 months performance status (PS) of 0 to 1 forced vital capacity in 1 second (FEV1) higher than 0.8 L measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). absolute neutrophil count (ANC) of ≥ 1500/μL hemoglobin ≥ 10 mg/dL platelet ≥ 100,000/μL serum creatinine ≤ 1.25 times of upper limit of normal (ULN) calculated creatinine clearance (CrCl) of ≥ 60 ml/min bilirubin 1.5×ULN AST and ALT less than 2.5×ULN alkaline phosphatase less than 5×ULN. Exclusion Criteria: active infection history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) malnutrition (loss of ≥ 20% of the original body weight) sensor or motor neuropathy > grade I second primary malignancy, except for non-melanoma skin cancer psychiatric illness or social situation that would preclude study compliance pregnant or lactating women preexisting bleeding diatheses or coagulopathy Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Chen, Doctor

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25497558

Citation

Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.

Results Reference

derived

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Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

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