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An open-label randomized and controlled clinical trial: This study was to compare the anticancer efficacy and safety in the First-Line Treatment in patients with Advanced Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with Cisplatin versus Paclitaxel Injection Containing Cremophor EL(polyoxyethylenated castor oil) In combination with Cisplatin in the way of an open-label, randomized controlled clinical trial.
Treatment Protocol:
The subjects were randomized in the Paclitaxel Micelles for Injection Group and the Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method was adopted in this trial. Since the study was a comparison of first-line treatment, the test for superiority was adopted. The objective response rate was the primary indicator of efficacy in this study.
Trial Group:
Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.
No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required for the patients before infusion of Paclitaxel Micelles for Injection patients.
Control Group:
Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.
Standard preventive treatment must be given to patients in accordance with the specific requirements in specifications of Paclitaxel Injection.
Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper limit.
To estimate the sample size based on objective remission indicators (CR + PR) in the study. Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined with Cisplatin in the Trial Group is different with that of first-line treatment of advanced non-small cell lung cancer, and is also different with that of the Cremophor EL-containing Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings: assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the proportion of 2: 1. According to the sample size formula , a total of 426 patients is required, including 284 patients assigned in the Trial Group and 142 in the Control Group. In consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468 cases were included in the groups, including 312 in the Trial Group and 156 in the Control Group.
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Inclusion criteria
First-line patients with locally advanced or metastatic NSCLC (Clinical Stage of ⅢB/Ⅳ, TNM (primary tumor, regional nodes, metastasis) Staging Edition 7) confirmed by histological or cytological diagnosis or of postoperative recurrence;
First-line patients include:
Patients with available measurable lesions in line with the requirements of "measurable lesions" in the response evaluation criteria "RECIST Version 1.1". Lesions with at least one accurately measurable diameter (serve as the maximum diameter): the maximum diameter of target lesions with CT scan ≥20 mm or the maximum diameter with spiral CT or MRI scan ≥10 mm;
ECOG (Eastern Cooperative Oncology Group) score ≤ 1 points and expected survival of at least 3 months;
18 to 70 years old, male or female;
Blood picture and functions of major organs such as heart, lung, liver, kidneys are basically normal.
Blood routine test must meet the following criteria:
Blood biochemical test must meet the following criteria:
Patients have no cardiac insufficiency symptoms at baseline; no serious abnormal signs in ECG
Efficacy of cancer-related imaging examinations are completed within 2 weeks before enrollment and clinical condition assessment, the three routine tests of blood, urea, and stool, blood biochemical examination, ECG, CEA (carcinoembryonic antigen) and other examinations completed within 1 week before enrollment;
Patients can understand the purpose of the clinical trial, participate out of their own will, and sign the informed consent;
Patients have good compliance, accept the doctor's follow-up evaluations, and voluntarily follow treatment protocol during the study;
Male or female patients with childbearing potential voluntarily take contraceptive measures during the trial.
Exclusion criteria
In case of any of the following circumstances, the patient is not allowed to participate in this study:
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454 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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