Clinical trial NCT02195453: Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Randomized,Double-blind,Placebo-Controlled,Multicenter Clinical Trail of Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
FACT-L scale
Yangzhengxiaoji
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2014-07-21
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Lung scale
timeFrame: 84day
measure: Lung Cancer Symptom Scale
timeFrame: 84day
Secondary outcomes:
measure: Anti-cancer drugs common grading evaluation of adverse reaction
timeFrame: 84day
measure: Completion of chemotherapy
timeFrame: 84 day
measure: Objective response rate
timeFrame: 84day
measure: Progression-free survival
timeFrame: 84 day
Other outcomes:
Locations:
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinming Yu, PhD
role: STUDY_CHAIR
affiliation: Biejing Cancer Hospital
name: Jie Wang, PhD
role: STUDY_CHAIR
References: