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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
recombinant human thrombopoietin
Sponsored by
Chinese Society of Lung Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.

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)

Outcomes

Primary Outcome Measures

minimum and maximum value of platelet count after chemotherapy
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

Secondary Outcome Measures

The duration when patient's platelet count remains below 50×109/L
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)

Full Information

First Posted
March 21, 2011
Last Updated
March 2, 2017
Sponsor
Chinese Society of Lung Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT01319669
Brief Title
Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
recruiting too slowly
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Society of Lung Cancer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
recombinant human thrombopoietin
Other Intervention Name(s)
rhTPO
Intervention Description
Recombinant human thrombopoietin injection in 15000U/ml/amp.
Primary Outcome Measure Information:
Title
minimum and maximum value of platelet count after chemotherapy
Description
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
Time Frame
nine weeks
Secondary Outcome Measure Information:
Title
The duration when patient's platelet count remains below 50×109/L
Description
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)
Time Frame
nine weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients at the age of 18 to 75 years old Histologically or cytologically diagnosed NSCLC cases Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L 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) Expected lifespan over 12 weeks With understanding ability and voluntarily sign informed consent form Be able to comply with the study and follow-up process Exclusion Criteria: With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled) 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 Breast-feeding or pregnant women Platelet count over 300×109/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Long Wu, Professor
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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