Clinical trial NCT05176067: Randomized Controlled Clinical Study of Drug Therapy Combined With Thoracic Radiotherapy for Non-oligometastatic NSCLC
Official title: Department of Thoracic Oncology, Affiliated Tumor Hospital of Guizhou Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stage IV Non-small Cell Lung Cancer
Lead sponsor: Guizhou Medical University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Clinical Study
Primary purpose: TREATMENT

Brief summary: To investigate whether radiotherapy combined with drug therapy is beneficial to non- oligometastatic stage IV NSCLC

Detailed description: Group A (targeted therapy, immunotherapy, chemotherapy); The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Group B (drug concurrent radiotherapy group: combined with thoracic primary tumor radiotherapy on the basis of targeted therapy, immune, chemotherapy ) The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Radiographic evaluation was performed after radiotherapy for the primary lesion of the chest.

Eligibility criteria: Inclusion Criteria:

1. Non- small cell lung cancer patients diagnosed by pathology or cytology;
2. Patients with stage IV non-oligometastasitatic \[Eighth Edition\];
3. initial treatment (no previous treatment);
4. age 18 \~ 80 years old, physical condition score ECOG 0 \~ 2 or KPS ≥ 60;
5. distance metastatic lesions: more than 5 metastatic lesions ; mind when brain metastases; The number of pulmonary metastases does not affect lung function, and radiotherapy for primary and/or partial metastases may be performed;
6. no contraindications such as radiotherapy, EGFR-TKI, chemotherapy, and immunotherapy;
7. primary tumor radiotherapy requires IMRT technology; In the plan design, the primary tumor prescription dose (DTGTV) was given under the damage control threshold standard, and the prescription dose was ≥ 40Gy; During the planned evaluation, the prescription dose includes 100% GTV, and 90% prescription dose includes 98% \~ 100% PTV \[planned target dose (DTP) ≥ 36Gy\]; Normal lung (whole lung volume minus GTV volume) V20 ≤ 32%, MLD ≤ 20GY; (V20 ≤ 25% in radiotherapy for patients with ALK, Ros-1, met, etc.).
8. radiotherapy for metastatic tumors is three-dimensional radiotherapy technology (IMRT / SRT / SBRT / VMAT, etc.), SBRT.
9. the subject has no dysfunction of main organs, or the laboratory test indicators must meet the following requirements: hematology: it is within the normal range according to the standards of each laboratory; Cardiac function: normal range; Liver function: normal range; Renal function: normal range; Pulmonary function: FEV1 \> 50%, mild to moderate impairment of pulmonary function.
10. The sign informed consent before treatment (radiotherapy, chemotherapy, immunization, targeted drug therapy);
11. patients have good compliance with the treatment and follow-up.

Exclusion Criteria:

1. Patients with pathological type, stage, and survival status that do not meet the inclusion criteria;
2. Stage IV NSCLC patients with serous effusion such as malignant pleural effusion and pericardial effusion;
3. Patients with extensive liver metastasis and intrapulmonary metastasis have seriously affected liver and lung function;
4. The patient had no control of hypertension, diabetes, unstable angina, history of myocardial infarction, or had congestive heart failure or cardiac arrhythmia in the past 12 months. Heart valve disease with definite clinical diagnosis; Disease activity period of bacterial, fungal, or viral infection; Mental disorders; Severe impairment of pulmonary function;
5. Pregnant and lactating patients;
6. Patients with a history of other active malignant tumors except for small cell lung cancer before enrollment; Non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and cured early prostate cancer are excluded;
7. Patients with the allergic constitution and known or suspected allergy to any drug in the study without alternative drugs;
8. Patients with poor compliance;
9. The researcher believes that it is not suitable to participate in this experiment

Primary outcomes:
measure: PFS
timeFrame: through study completion, an average of 1 year
measure: ORR
timeFrame: through study completion, an average of 1-2 years
Secondary outcomes:
measure: Toxicity and side effecttion
timeFrame: through study completion, an average of 1-2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University
name: Bing Lu, bachelor
role: STUDY_CHAIR
References: