Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02195453
• Other study ID #: yl-yxb08-lcsyfa-201302
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 7, 2014
• Last updated: July 17, 2014
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: Shandong Cancer Hospital and Institute
• Contact: Ligang Xing, M.D.
• Phone: 18053100188
• Email: xinglg[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 520
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Histology and/or cytology confirmed stage ? 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 ?-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Yangzhengxiaoji 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.
• Placebo 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute	Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy-Lung scale		84day	Yes
Primary	Lung Cancer Symptom Scale		84day	Yes
Secondary	Anti-cancer drugs common grading evaluation of adverse reaction		84day	Yes
Secondary	Completion of chemotherapy		84 day	Yes
Secondary	Objective response rate		84day	Yes
Secondary	Progression-free survival		84 day	Yes