Clinical trial NCT01218594: Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Stage III
Unresectable
Non-small cell lung cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Guangdong Medical University
name: Fujian Province Tumor Hospital
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: The Affiliated Tumor Hospital of Guangxi Medical University
name: Zhejiang Cancer Hospital
name: Guangzhou General Hospital of Guangzhou Military Command
name: The 458 Hospital of Chinese PLA
First posted: 2010-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response Rate (RR)
timeFrame: 4 weeks after CCRT
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Chen, Doctor
role: STUDY_CHAIR
References:
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.