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

NCT04284215 | Unknown

• 1 other identifier: GuizhouMu
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Efficacy and Safety

Outcome Measures

Primary Outcomes (1)

• ORR

  Efficacy of Concurrent chemoradiotherapy

  2 years

Secondary Outcomes (1)

• Side effection

  2 years

Study Arms (2)

Albumin paclitaxel

EXPERIMENTAL

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

Drug: Albumin paclitaxel combined with cisplatin

Paclitaxel

ACTIVE COMPARATOR

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

Drug: Albumin paclitaxel combined with cisplatin

Interventions

Albumin paclitaxel combined with cisplatin DRUG

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 chemotherapy can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy.

Also known as: Albumin paclitaxel

Albumin paclitaxel; Paclitaxel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guizhou Medical University: lead

Study Sites (1)

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

Location

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Bing Lu, Bachelor

  Affiliated Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: February 25, 2020
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: February 25, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)