Efficacy and Safety of Albumin Paclitaxel Combined With Cisplatin Chemoradiotherapy for Non-resectable Stage III NSCLC

Not Applicable

• Conditions: Efficacy and Safety
• Interventions: Drug: Albumin paclitaxel combined with cisplatin

• Registration Number: NCT04284215
• Lead Sponsor: Guizhou Medical University

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 investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity. To determine whether paclitaxel albumin combined with cisplatin regimen can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy

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 toxicity and heart problems can replace DDP)\]Repeated every 3-4 weeks for 4 consecutive cycles (21-28 days/cycle, minimum 2 cycles). In the experimental group, albumin paclitaxel 40 mg/m2/week was injected into saline at the same time as radiotherapy, once a week. Cisplatin 75 mg/m2 was given intravenously for 2-3 days (2-4 days), carboplatin 300 mg/m2 and 2 days. (Because toxicity and heart problems can replace DDP)\] Repeat every 3-4 weeks for 4 consecutive cycles (21-28 days/cycle, minimum 2 cycles). Three-dimensional radiotherapy: intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation Dose: DTGTV: \> 60Gy treatment sequence: Chemotherapy started within one week after completion of pre-treatment evaluation. Radiotherapy for primary thoracic tumors was performed simultaneously on the first day of chemotherapy. Chemotherapy effectiveness was evaluated by radiological examination within one week after the completion of the second cycle of chemotherapy.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-09-01
• Study First Submitted: 2019-09-14
• Study First Submitted QC: 2020-02-22
• Last Update Submitted: 2020-02-22
• Study First Posted: 2020-02-25
• Last Update Posted: 2020-02-25
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin paclitaxel	Albumin paclitaxel combined with cisplatin	Albumin paclitaxel 40mg/m2/week was injected into normal saline at the same time as radiotherapy, once a week. Cisplatin 75 mg/m2 was given intravenously for 2-3 days , carboplatin 300 mg/m2 and 2 days. (Because toxicity and heart problems can replace DDP)\] Repeat every cycle (21-28 days/cycle, minimum 2 cycles). Three-dimensional radiotherapy: intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation; Dose: DTGTV: \> 60 Gy
Paclitaxel	Albumin paclitaxel combined with cisplatin	Paclitaxel 175 mg/m2 was injected into saline solution on the first day. Cisplatin 75 mg/m2 was given intravenously for 2-3 days , carboplatin 300 mg/m2 and on the second day. (Because toxicity and heart problems can replace DDP)\]Repeated every cycle (21-28 days/cycle, minimum 2 cycles). Three-dimensional radiotherapy: intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation; Dose: DTGTV: \> 60 Gy

Primary Outcome Measures

Name	Time	Method
ORR	2 years	Efficacy of Concurrent chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
Side effection	2 years	bone marrow suppression, hepatic and renal toxicity, cardiac toxicity, radiation pneumonia and other toxic and side effects caused by treatment

Trial Locations

Locations (1)

Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China