NCT02195453

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for phase_4 nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4 nonsmall-cell-lung-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

July 7, 2014

Last Update Submit

July 17, 2014

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-small cell lung cancerFACT-L scaleYangzhengxiaoji

Outcome Measures

Primary Outcomes (2)

  • Functional Assessment of Cancer Therapy-Lung scale

    84day

  • Lung Cancer Symptom Scale

    84day

Secondary Outcomes (4)

  • Anti-cancer drugs common grading evaluation of adverse reaction

    84day

  • Completion of chemotherapy

    84 day

  • Objective response rate

    84day

  • Progression-free survival

    84 day

Study Arms (2)

Yangzhengxiaoji Capsule

EXPERIMENTAL

Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po

Drug: Yangzhengxiaoji Capsule

Placebo Capsule

PLACEBO COMPARATOR

Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po

Drug: Placebo Capsule

Interventions

Yangzhengxiaoji CapsuleDRUG

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.

Yangzhengxiaoji Capsule
Placebo CapsuleDRUG

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.

Placebo Capsule

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histology and/or cytology confirmed stage Ⅳ NSCLC patients;
  • 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;
  • Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival \> 3 months;
  • Age: 18-70 years;
  • 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;
  • For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms;
  • Informed consent.

You may not qualify if:

  • 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;
  • Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization;
  • Spleen resection or combined with other severe hematopoietic system diseases;
  • Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers;
  • 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;
  • Mental illness, without legal capacity or limited capacity;
  • Pregnancy, lactation or patients with pregnancy plan;
  • Participated in other clinical trail in the past 1 months or participating in other trail now;
  • Other unsuitable condition decided by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jinming Yu, PhD

    Shandong Cancer Hospital and Institute

    STUDY CHAIR

  • Jie Wang, PhD

    Biejing Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Ligang Xing, M.D.

CONTACT

18053100188xinglg@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shandong Cancer Hospital and Institute

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 21, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2014

Record last verified: 2014-07