Non-small Cell Lung Cancer
Conditions
Keywords
Stage III, Unresectable, Non-small cell lung cancer
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.
Interventions
DRUGEndostatin
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Sponsors
Affiliated Hospital of Guangdong Medical University
Fujian Province Tumor Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
The Affiliated Tumor Hospital of Guangxi Medical University
Zhejiang Cancer Hospital
Guangzhou General Hospital of Guangzhou Military Command
The 458 Hospital of Chinese PLA
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Participant flow
Recruitment details
Between May 2009 and January 2012, 50 patients from 5 centers were enrolled onto the study.
Pre-assignment details
Two patients refused treatment after consenting for therapy and were ultimately excluded from the trial before any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Endostar Plus CCRT Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\
66 Gy. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Endostar Plus CCRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age Continuous | 55 years STANDARD_DEVIATION 10 |
| Region of Enrollment China | 48 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 48 |
| serious Total, serious adverse events | 2 / 48 |
Outcome results
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).
Time frame: 4 weeks after CCRT
Population: Response rate (RR)include complete response and partial response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endostar Plus CCRT | Response Rate (RR) | 37 percentage of participants |