Randomized Controlled Clinical Study of Drug Therapy Combined With Thoracic Radiotherapy for Non-oligometastatic NSCLC

NCT ID: NCT05176067

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2023-12-31

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.

Conditions

Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

drug therapy group

targeted therapy, immune, chemotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

drug therapy concurrent radiotherapy

drug therapy(targeted therapy, immune, chemotherapy ) combined with thoracic tumor concurrent radiotherapy

Group Type: EXPERIMENTAL

Thoracic Three-dimensional Radiotherapy

Intervention Type: RADIATION

Drug Therapy Combined With Thoracic Three-dimensional Radiotherapy

Interventions

Thoracic Three-dimensional Radiotherapy

Drug Therapy Combined With Thoracic Three-dimensional Radiotherapy

Intervention Type: RADIATION

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guizhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bing Lu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Lu, bachelor

Role: STUDY_CHAIR

Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University

Central Contacts

Wengang Yang, postgraduate

Role: CONTACT

minyangtom@sohu.com

13984148911

Other Identifiers

Guizhou MU

Identifier Type: -

Identifier Source: org_study_id