Status:
UNKNOWN
Efficacy and Safety of Albumin Paclitaxel Combined With Cisplatin Chemoradiotherapy for Non-resectable Stage III NSCLC
Lead Sponsor:
Guizhou Medical University
Conditions:
Efficacy and Safety
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy. Paclitaxel and platinum are commonly used in chemotherapy regimens. The aim of this study was to in...
Detailed Description
Control group: Paclitaxel 175 mg/m2 was injected into saline solution on the first day. Cisplatin 75 mg/m2 was given intravenously for 2-3 days (2-4 days), carboplatin 300 mg/m2 and 2 days. (Because t...
Eligibility Criteria
Inclusion
- Patients with NSCLC confirmed by pathology or cytology; clinical stage III \[AJCC 8th Edition stage\];
- Informed consent signed before treatment (radiotherapy, chemotherapy);
- no contraindication of radiotherapy and chemotherapy; .IMRT or VMAT technology is required to achieve the prescription dose of primary tumor (DTGTV): \> 60Gy, normal lung in the design of radiotherapy plan.
- (Total Lung Volume minus GTV Volume) V20 \< 32% were randomly enrolled in the study. \[Planning Assessment: Prescription dose includes 100% GTV, 90% .prescription dose includes 98%\~100% PTV\] \[Age 18-80 years old, body condition score ECOG0-2 or KPS (\>70) \];
- \[Subjects had no major organ dysfunction, blood routine, lung, liver and kidney. With normal function and cardiac function, laboratory tests must meet the following requirements: leukocyte (\>4.0 \*109/L), neutrophil (\>2.0 \*109/L), platelet (\>100 \*109/L) and hemoglobin (\>100 g/L). Liver function: normal range. Renal function: normal range .Lung function: FEV1 \> 50%, mild to moderate lung function impairment. \_Patients have good compliance with the treatment and follow-up.
Exclusion
- Pathological types, stages and survival status of patients who did not meet the criteria for enrollment
- Patients with uncontrollable hypertension, diabetes mellitus, unstable angina, history of myocardial infarction or symptomatic congestive heart failure or uncontrollable arrhythmia in the past 12 months; .Clinically diagnosed valvular disease; active period of bacterial, fungal or viral infections; mental disorders; and severe heart failure.
- Pulmonary impairment; Pregnancy and lactation patients;
- Patients with a history of active malignancies other than small cell lung cancer before admission;
- Patients with non-melanoma skin basal cell carcinoma, cervical cancer in situ, and cured early prostate cancer except; .Allergic constitution and known or suspected drug allergy in any study. .Patients without alternative drugs, patients with poor compliance, and researchers do not consider it appropriate to participate in this study.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04284215
Start Date
September 1 2019
End Date
October 30 2021
Last Update
February 25 2020
Active Locations (1)
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1
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550001