Non-Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, FACT-L scale, Yangzhengxiaoji
Brief summary
The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.
Interventions
DRUGYangzhengxiaoji Capsule
Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle. Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle. Yangzhengxiaoji Capsule four granules t.i.d po.
DRUGPlacebo Capsule
Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle. Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle. Placebo Capsule four granules t.i.d po.
Sponsors
Peking University Cancer Hospital & Institute
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histology and/or cytology confirmed stage Ⅳ NSCLC patients; 2. With at least one measurable solid tumor (RECIST standard version 1.1): tumor \>=10 mm in diameter on CT or MRI images, or lymph node \>=15 mm in diameter on CT or MRI images; 3. Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival \> 3 months; 4. Age: 18-70 years; 5. Normal organ function: Bone marrow: neutrophils (ANC) count\>=1.5×10\^9/L, Platelets count\>=100×10\^9/L, hemoglobin\>=90g/L；Renal function, serum creatinine\<=1.5 mg/dl, and/or creatinine clearance or\>=60 ml/min; Liver function: total serum bilirubin levels \<= 1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)\<=2.5 times the ULN, if abnormal liver function caused by the underlying malignancy, the AST and ALT \>=5 times ULN; 6. For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms; 7. Informed consent.
Exclusion criteria
1. Clinically significant hepatic dysfunction: AST or ALT \> 2.5 times the ULN, total serum bilirubin levels \> 1.5 times the ULN; clinically significant renal insufficiency: serum creatinine \> 1.5 times the ULN; 2. Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization; 3. Spleen resection or combined with other severe hematopoietic system diseases; 4. Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers; 5. History or present with other cancer, except for non melanoma skin cancer, cervical cancer in situ and other cured cancer for at least 5 years; 6. Mental illness, without legal capacity or limited capacity; 7. Pregnancy, lactation or patients with pregnancy plan; 8. Participated in other clinical trail in the past 1 months or participating in other trail now; 9. Other unsuitable condition decided by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Assessment of Cancer Therapy-Lung scale | 84day |
| Lung Cancer Symptom Scale | 84day |
Secondary
| Measure | Time frame |
|---|---|
| Anti-cancer drugs common grading evaluation of adverse reaction | 84day |
| Completion of chemotherapy | 84 day |
| Objective response rate | 84day |
| Progression-free survival | 84 day |
Contacts
Primary ContactLigang Xing, M.D.
Outcome results
None listed