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

• ClinicalTrials.gov Identifier: NCT02195453
• Recruitment Status: Unknown
• First Posted: July 21, 2014
• Last Update Posted: July 21, 2014
• Sponsor: Shandong Cancer Hospital and Institute
• Collaborator: Beijing Cancer Hospital
• Information provided by (Responsible Party): Jinming Yu, Shandong Cancer Hospital and Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: Yangzhengxiaoji Capsule; Drug: Placebo Capsule	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 520 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: August 2014
• Estimated Primary Completion Date: September 2016
• Estimated Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Yangzhengxiaoji Capsule; Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po	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 Comparator: Placebo Capsule; Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Functional Assessment of Cancer Therapy-Lung scale [ Time Frame: 84day ]
2. Lung Cancer Symptom Scale [ Time Frame: 84day ]

Secondary Outcome Measures :

1. Anti-cancer drugs common grading evaluation of adverse reaction [ Time Frame: 84day ]
2. Completion of chemotherapy [ Time Frame: 84 day ]
3. Objective response rate [ Time Frame: 84day ]
4. Progression-free survival [ Time Frame: 84 day ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Ligang Xing, M.D.; 18053100188; xinglg@gmail.com

Sponsors and Collaborators

Shandong Cancer Hospital and Institute

Beijing Cancer Hospital

Investigators

• Study Chair: Jinming Yu, PhD; Shandong Cancer Hospital and Institute
• Study Chair: Jie Wang, PhD; Biejing Cancer Hospital

More Information

• Responsible Party: Jinming Yu, Shandong Cancer Hospital and Institute
• ClinicalTrials.gov Identifier: NCT02195453
• Other Study ID Numbers: yl-yxb08-lcsyfa-201302
• First Posted: July 21, 2014
• Last Update Posted: July 21, 2014
• Last Verified: July 2014

Keywords provided by Jinming Yu, Shandong Cancer Hospital and Institute:

Non-small cell lung cancer; FACT-L scale; Yangzhengxiaoji

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms