A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II study compare survival outcomes and toxicity of malignant pleural effusion stage IV non small-cell lung cancer patients Intrapleural infusion chemotherapy in combination with concurrent thoracic radiation therapy (TRT) VS not combination with concurrent thoracic radiation therapy (TRT).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guizhou Medical University

Criteria

Inclusion Criteria:

• Patients with pathological or cytological diagnosis, stage IV with malignant pleural effusion [UICC 2017 staging eighth edition] NSCLC patients;

• initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood);

• Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases;

• no radiotherapy, EGFR-TKI and chemotherapy contraindications;

• primary tumor radiotherapy requires IMRT technology;

• Plan the design to give the primary tumor prescription dose (DTGTV) under the damage control threshold criteria;

• The planned dose includes 100% GTV, 90% of the prescribed dose includes 98%~100% of PTV [planned target dose (DTPTV)]; normal lung (full lung volume minus GTV volume) V20 ≤ 32%, MLD≤20Gy;

• metastatic tumor radiotherapy is a three-dimensional radiotherapy technique (IMRT/SRT/SBRT/VMAT, etc.), and large-segment radiotherapy.

• Subjects have no major organ dysfunction, or laboratory test indicators must meet the following requirements: Hematology: normal range according to laboratory standards; cardiac function: normal range; liver function: normal range; renal function: normal range Lung function: FEV1>50%, impaired light-moderate lung function.

• Informed consent (radiation, medication) before treatment;

• The patient has good compliance with the treatment and follow-up received.

Exclusion Criteria:

• Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria;

• no malignant pleural effusion IV stage NSCLC;

• patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function;

• Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease; • • •Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function;

• pregnant, lactating patients;

• Patients with a history of other active malignancies other than small cell lung cancer before entering the group; non-melanoma skin basal cell carcinoma, in situ cervical cancer, and cured early prostate cancer;

• Patients with allergies and no known alternatives to known or suspected drugs in any study;

• Patients with poor compliance;

• Researchers believe that it is not appropriate to participate in this test.