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

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01218594
• Other study ID #: DP-EN-RT
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 1, 2010
• Last updated: September 17, 2012
• Start date: May 2009
• Est. completion date: December 2015

Study information

• Verified date: August 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (8)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 weeks after CCRT	Yes