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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)


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

minimum and maximum value of platelet count after chemotherapy

Outcome 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

Outcome Time Frame:

nine weeks

Safety Issue:

No

Principal Investigator

Yi-Long Wu, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital

Authority:

China: Food and Drug Administration

Study ID:

C-TONG1001

NCT ID:

NCT01319669

Start Date:

February 2011

Completion Date:

February 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Thrombocytopenia

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