Non Small Cell Lung Cancer Clinical Trial
Official title:
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials
Verified date | February 2016 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC
Status | Completed |
Enrollment | 84 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
1.18~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of
IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by
CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory
values: - leucocyte = 4×109/L - neutrophil = 1.5×109/L - platelet = 100×109/L - Hemoglobin = 10g/L - ALT and - AST = 2.5×ULN (= 5×ULN if liver metastasis) 7.Signed written informed consent Exclusion Criteria: - Patients have used drugs according to protocol - Patients were allergic to pemetrexed or cisplatin - Patients received radiotherapy or other biological treatment 4 weeks before the trial - Uncontrolled hydrothorax or hydropericardium - neuropathy toxicity = CTC 3 - Severe symptomatic heart disease - Active upper gastrointestinal ulcer or digestive disfunction - Severe infection or metabolic disfunction - Patients with other malignant tumor - Uncontrolled brain metastases - Patients have accepted other clinical trials - Female patients during their pregnant and lactation period, or patients without contraception |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Cancer hospital Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | from the first cycle of treatment (day one) to two month after the last cycle | No |
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