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

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ClinicalTrials.gov Identifier: NCT02195453
Recruitment Status : Unknown
Verified July 2014 by Jinming Yu, Shandong Cancer Hospital and Institute.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Jinming Yu, Shandong Cancer Hospital and Institute

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195453


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

Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Beijing Cancer Hospital
Investigators
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Study Chair: Jinming Yu, PhD Shandong Cancer Hospital and Institute
Study Chair: Jie Wang, PhD Biejing Cancer Hospital
More Information
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Responsible Party: Jinming Yu, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02195453     History of Changes
Other Study ID Numbers: yl-yxb08-lcsyfa-201302
First Posted: July 21, 2014    Key Record Dates
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:
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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
Gemcitabine
Cisplatin
Pemetrexed
 Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors