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

Phase 3TerminatedNCT01319669

Chinese Society of Lung Cancer11 enrolled

Overview

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)

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

recombinant human thrombopoietinDRUG

Recombinant human thrombopoietin injection in 15000U/ml/amp.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Time frame: nine weeks

Secondary Outcomes

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)

Time frame: nine weeks

Data from ClinicalTrials.gov

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