Clinical trial NCT01733589: Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
Official title: Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage III Non-small-Cell Lung Cancer
Keywords: Recombinant human endostatin
Non-small-Cell Lung Cancer
chemoradiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
name: Fudan University
name: Peking University Cancer Hospital & Institute
name: Tianjin Medical University Cancer Institute and Hospital
name: Shandong Cancer Hospital and Institute
name: Jiangsu Cancer Institute & Hospital
name: Fujian Cancer Hospital
name: The First People's Hospital of Lianyungang
First posted: 2012-11-27
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Detailed description: Primary

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).

Secondary

Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.

Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

Eligibility criteria: Inclusion Criteria:

* untreated histologic or cytologic of NSCLC verified
* inoperable stage IIIA or IIIB NSCLC
* measurable disease by RECIST
* 18\~70 years of age
* an ECOG PS of 0 to 1
* absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
* serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
* bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
* forced vital capacity in 1 second (FEV1) higher than 0.8 L
* CB6 is normal
* Written informed consent

Exclusion Criteria:

* a history of other malignant diseases
* any contraindications for chemoradiotherapy
* distant metastasis
* malignant pleural and/or pericardial effusion
* pregnant or nursing
* preexisting bleeding diatheses or coagulopathy

Primary outcomes:
measure: progression-free survival
timeFrame: 2-year
Secondary outcomes:
measure: Response rate
timeFrame: 1 month
measure: overall survival
timeFrame: 5 years
measure: treatment related toxicities
timeFrame: 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ming Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: