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Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319669
Recruitment Status : Terminated (recruiting too slowly)
First Posted : March 22, 2011
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer

Tracking Information
First Submitted Date  ICMJE March 21, 2011
First Posted Date  ICMJE March 22, 2011
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
minimum and maximum value of platelet count after chemotherapy [ Time Frame: nine weeks ]
To evaluate the minimum and maximum value of platelet count after chemotherapy and the value of platelet count and their D-values comparing with the baseline values
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
The duration when patient's platelet count remains below 50×109/L [ Time Frame: nine weeks ]
The duration when patient's platelet count remains below 50×109/L, the time (in day) when patient's platelet count increases over 75×109/L and 100×109/L, the amount of platelet infused (number of units of apheresis platelet should be transformed into number of units of platelet concentrate)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy
Official Title  ICMJE Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy With GC/GP Regimens for Non-small-cell Lung Carcinoma Using Recombinant Human Thrombopoietin (rhTPO)
Brief Summary To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)
Detailed Description

This is a randomized, controlled, open-labeled, multicenter clinical trial. The subjects are patients with NSCLC who are going to receive GC/GP regimen chemotherapy.

Vadhan-Raj et al conducted a study in which they administered rhTPO in various ways to patients with sarcoma receiving platinum-containing chemotherapy. The results demonstrated that timing of administration of rhTPO can be adjusted according to the occurrence time of nadir platelet values induced by chemotherapy. The timing of administration of rhTPO in this study was determined based on the above proofs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: recombinant human thrombopoietin
Recombinant human thrombopoietin injection in 15000U/ml/amp.
Other Name: rhTPO
Study Arms  ICMJE
  • Experimental: Treatment group
    rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.
    Intervention: Drug: recombinant human thrombopoietin
  • Active Comparator: Control group
    15000U of rhTPO(recombinant human thrombopoietin) is given subcutaneously 6 to 24 hours within the end of chemotherapy cycle, that is, the 8th day for 3 consecutive days (d9 to d11)
    Intervention: Drug: recombinant human thrombopoietin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2011)
120
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients at the age of 18 to 75 years old
  2. Histologically or cytologically diagnosed NSCLC cases
  3. Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L
  4. Fit for chemotherapy (WBC ≥ 4.0×109/L;neutrophil count> 1.5×109/L;PLT ≥ 80×109/L;ALT ≤ 3 times the upper limit of normal range;AST ≤ 3 times the upper limit of normal range;TBil ≤ twice the upper limit of normal range;ECOG PS ≤ 2;without severe cardiopulmonary defects)
  5. Expected lifespan over 12 weeks
  6. With understanding ability and voluntarily sign informed consent form
  7. Be able to comply with the study and follow-up process

Exclusion Criteria:

  1. With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases
  2. With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled)
  3. With heart cerebrovascular diseases, congestive heart failure with NYHA above II degree, with unstable angina pectoris, with acute myocardial infarction or cerebral infarction within 6 months
  4. Breast-feeding or pregnant women
  5. Platelet count over 300×109/L
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01319669
Other Study ID Numbers  ICMJE C-TONG1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi-Long Wu, Chinese Society of Lung Cancer
Study Sponsor  ICMJE Chinese Society of Lung Cancer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yi-Long Wu, Professor Guangdong Provincial People's Hospital
PRS Account Chinese Society of Lung Cancer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP