Non Small Cell Lung Cancer Metastatic, Radiotherapy
Conditions
Keywords
non-oligometastatic NSCLC, radical radiotherapy of the primary lung lesion, pharmacotherapy with radiotherapy for the primary lesion
Brief summary
For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical research on combining pharmacotherapy with radiotherapy for the primary lesion in non-oligometastatic patients. Therefore, this study aims to investigate whether radical radiotherapy targeting the primary lung lesion, in addition to pharmacotherapy, can improve local control and survival in non-oligometastatic patients, and whether the associated toxicities are acceptable.
Interventions
RADIATIONThree-Dimensional Radiotherapy for Primary lungTumors
The experimental group received radical radiotherapy for the primary lung lesion in combination with first-line drug therapy recommended by the NCCN guidelines.
Sponsors
Guizhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically or cytologically confirmed stage IV NSCLC \[9th edition, 2024\]; 2. Non-oligometastatic disease (number of metastatic lesions \> 5, regardless of the number of organs involved); patients with brain metastases must be conscious; the number of lung metastases must not affect lung function and allow for possible primary tumor radiotherapy; 3. Treatment-naïve (no prior antitumor therapy); or disease control after 1-3 months of monotherapy with TKI, ALK inhibitor/ROS inhibitor; or disease control after 4-6 cycles of chemotherapy combined with immunotherapy; 4. Age 18-80 years, ECOG 0-2 or KPS ≥70; no contraindications to radiotherapy, EGFR-TKI, ALK/ROS1 inhibitors, chemotherapy, or immunotherapy; 5. No major organ dysfunction, or laboratory test results must meet the following criteria: Hematology , cardiac function, liver function , and renal function within normal ranges according to respective laboratory standards. Pulmonary function : FEV1 \>50%, mild to moderate impairment of lung function. 6. Signed informed consent before treatment (for radiotherapy, chemotherapy, immunotherapy, and targeted drug therapy); 7. Good patient compliance with the treatment and follow-up.
Exclusion criteria
1. Stage I-III NSCLC, oligometastasis (number of metastatic lesions ≤ 5), Stage IV NSCLC with malignant serous cavity effusion, or KPS ≤ 60; 2. Patients with extensive liver metastases or lung metastases that have severely impaired liver or lung function; 3. Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; clinically diagnosed valvular heart disease; active bacterial, fungal, or viral infections; mental disorders; severe pulmonary dysfunction; 4. Pregnant or lactating patients; 5. Patients with a history of other active malignant tumors prior to enrollment, except for non-small cell lung cancer; excluding non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and cured early-stage prostate cancer; 6. Patients with allergic constitution or known/suspected allergy to any investigational drugs without alternative medications; 7. Patients with poor compliance; Patients deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival, Local regional progressive-free survival, LRPFS | From enrollment to the end of treatment at 1 year | OS refers to the period the date of randomization in a clinical trial until the patient dies from any cause. Local progression-free survival time refers to the duration from randomization until the first occurrence of local progression at the primary tumor site or region, or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR, | From enrollment to the end of treatment at 1year. | ORR define the objective response rate according to RECIST version 1.1. |
| PFS | From enrollment to the end of treatment at 1 year | PFS, definehe length of time during and after treatment that a patient lives with the disease but it does not get worse. It is typically measured from the start of treatment until disease progression or death from any cause. |
| Toxicities | From enrollment to the end of treatment at 1 year | Toxicities: The primary assessment of radiotherapy-related toxicities is based on the CTC 5.0 criteria, focusing on treatment-related toxicities such as radiation pneumonitis, radiation esophagitis, bone marrow suppression, and hematologic toxicities affecting the liver and kidneys. And the time without cancer worsening or death |
Contacts
CONTACTBing Lu
Outcome results
None listed