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

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

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).

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Endostatin

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endostatin combine CCRT; 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks	Drug: Endostatin; 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks; Other Names: Endostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Zhejiang Cancer Hospital; Fifth Affiliated Hospital, Sun Yat-Sen University; Guangzhou General Hospital of Guangzhou Military Command; Fujian Province Tumor Hospital; The Affiliated Tumor Hospital of Guangxi Medical University; The 458 Hospital of Chinese PLA; Affiliated Hospital of Guangdong Medical University
• Investigators: Study Chair: Ming Chen, Doctor, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 1, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): October 17, 2012
• Last Update Submitted That Met QC Criteria: September 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; Unresectable; Stage III
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostatins
• Other Study ID Numbers: DP-EN-RT