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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Endostatin

• Registration Number: NCT01218594
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Status Verified: 2012-08
• Results First Submitted: 2012-08-19
• Results First Submitted QC: 2012-09-17
• Last Update Submitted: 2012-09-17
• Results First Posted: 2012-10-17
• Last Update Posted: 2012-10-17
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostatin combine CCRT	Endostatin	7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Primary Outcome Measures

Name	Time	Method
Response Rate (RR)	4 weeks after CCRT	Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China