Have you or your loved ones been diagnosed with non-small cell lung cancer?

You may be eligible to participate in a non-small cell lung cancer clinical trial.

Have you or your loved ones been diagnosed with non-small cell lung cancer? You may be eligible to participate in a non-small cell lung cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Non-small Cell Lung Cancer Clinical Trial in GuangZhou Guangdong

NCT01882621 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with non-small cell lung cancer?

You may be eligible to participate in a non-small cell lung cancer clinical trial.

Have you or your loved ones been diagnosed with non-small cell lung cancer? You may be eligible to participate in a non-small cell lung cancer clinical trial.

Unknown status

Male & Female

All ages

This study is looking to recruit 300 Participants

Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin

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Details for the study

Brief Title

Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients

Official Title

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by First-line Chemotherapy Contained Cisplatin in Non-small Cell Lung Cancer Patients.

Brief Summary

Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity<br /> induced by cisplatin

Detailed Description

NSCLC patients received a cisplatin-based doublet chemotherapy are included in this trial.
Patients are randomly assigned into the experimental group and control group based on
segmented block randomized method. After enrollment, patients should complete four or six
chemotherapy and GM1/placebo injection. During the 3w per cycle chemotherapy, cisplatin
injection is conducted in D1/D1-3, GM1/placebo (80mg+250ml N.S) is injected from D0 to D3.
Neurotoxicity evaluation and quality of life (FACT-NTX and EROTC scale) assessment will be
conducted every cycle and 3w/11w/19w after the chemotherapy.

Treatments and/or Procedures

Monosialoganglioside GM 1

80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Normal saline

80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Study Criteria

Inclusion Criteria:

  -  Cytological and histological confirmation of non-small cell lung cancer (NSCLC)
     diagnosis, single sputum cytology diagnosis is not accepted

  -  Expected survival period is more than 3 months

  -  Enough blood function reservation: absolute neutrophil count (ANC) 2 x 10E9/L or
     higher;platelet count 100 x 109 /L or higher;hemoglobin 9 g/dL or higher.

  -  Enough liver function reservation:the total bilirubin less than upper limit of
     normal;AST and ALT acuities were less than 2.5 times the upper limit of normal
     (ULN);Alkaline phosphatase 5 times the upper limit of normal (ULN) or less.

  -  Clinical doctors identify patients suitable for standard doses of ganglioside drug
     therapy, and expected time of medication is at least six weeks

  -  Within 4 weeks before treatment, did not receive other adverse reaction of drugs may
     cause similar neurotoxicity; 18 weeks before, did not received platinum-based drugs
     chemical treatment.

  -  No more than 1 degree of the peripheral nervous system diseases exists before
     enrollment, also no other symptom or disease could affect the adverse reactions of
     neurotoxicity pathological.

  -  Can't accept other adverse reactions may prevent neurotoxicity treatment or care after
     enrollment.

  -  Sign the informed consent form.

Exclusion Criteria:

  -  Patients with poor general condition, PS score more than 2 points

  -  Women in pregnancy or lactation

  -  Patients (male or female) have fertility possibility but not willing to or not to
     adopt effective contraception

  -  With other neurological dysfunction which can cause inaccurate record of the
     occurrence of neurotoxicity and severity

  -  Known or assignment of any of these products to test drugs allergic agent composition

  -  Doctors think inappropriate for patients with ganglioside medication or estimated time
     of less than 6 weeks

  -  Active infection (determined by the researcher)

  -  According to the researcher's judgment, there is serious disease to endanger the
     safety of patients, or may prevent the patients from completing the study

  -  Have a clear history of neurological or psychiatric disorders, including epilepsy or
     dementia