A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC (NCT03987087) | Clinical Trial Compass
UnknownPhase 2
A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC
China68 participantsStarted 2018-09-01
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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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-modera…