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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.


Phase 2
N/A
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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.


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, 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

incidence rate of neurotoxicity adverse events

Outcome Time Frame:

up to 19 weeks after cisplatin chemotherapy

Safety Issue:

Yes

Principal Investigator

LI Zhang, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

GM1-0324

NCT ID:

NCT01882621

Start Date:

June 2013

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Monosialoganglioside(GM1)
  • neurotoxicity
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neurotoxicity Syndromes

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