Quality of Life
Conditions
Keywords
Recombinant human endostatin, NSCLC, chemoradiotherapy
Brief summary
To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).
Interventions
COMBINATION_PRODUCTconcurrent chemoradiotherapy (CCRT)
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
DRUGEndostar for one cycle
Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1).
DRUGEndostar for two cycles
Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Affiliated Hospital of North Sichuan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Patients were randomly assigned to a regimen of W1-CCRT(one treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or W2-CCRT(two treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or CCRT.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female patients, age: 18-70 years of age * 2\. Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b. * 3\. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy. * 4\. Eastern Cooperative Oncology Group (ECOG) test scored 0-1. * 5\. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L. * 6\. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min. * 7\. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL. * 8\. Forced vital capacity rate of one second（FEV1）\>0.8 litre. * 9\. Coagulation function is normal * 10\. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard * 11\. Sign the inform consent form with good compliance
Exclusion criteria
* 1\. Carcinoid or small cell lung cancer * 2\. Patients with any distant metastasis * 3\. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix * 4\. Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy). * 5\. Pregnancy or breastfeeding women * 6\. Women who may be pregnant but are unwilling to take appropriate contraception * 7\. Hereditary bleeding or coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival (PFS) | 4 years | Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | 4 years | comparison to maintenance chemoradiotherapy alone |
| Treatment-related toxicity | 4 years | Toxicity and adverse events related to the inventions |
Countries
China
Contacts
Primary ContactDaiyuan Ma, M.D
Outcome results
None listed