TRT for ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
Study Details
Study Description
Brief Summary
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TRT Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy. |
Radiation: Thoracic radiotherapy
Thoracic radiotherapy for ES-SCLC after first line immunecheckpoint inhibitors
|
Outcome Measures
Primary Outcome Measures
- Local recurrence free survival [2 years]
From the date of enrollment to the date of local recurrence
- Adverse events [2 years]
Treatment-related adverse events according to CTCAE 5.0.
Secondary Outcome Measures
- Progress free survival [2 years]
From the date of enrollment to the date of disease progression
- Overall survival [2 years]
from the date of enrollment until death by any cause or last follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age at least 18 years.
-
ECOG PS 0-1.
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Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive
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Life expectancy >= 3 months.
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Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions
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Palliative radiotherapy were allowed except for TRT, the interval > 4 weeks
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Adequate organ function prior to enrollment:
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Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, platelet count ≥ 100 * 10 ^ 9/L and hemoglobin ≥90g/L,;
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Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN;
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Sufficient heart and lung function, EF>55%FEV1>50%
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Ability to understand and willingness to provide the informed consent.
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Women of childbearing age and men must agree to use effective contraception during the trial.
Exclusion Criteria:
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History of another malignancy or concurrent malignancy;
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Mixed small cell with non-small cell lung cancer histology;
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History of thoracic radiotherapy;
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Malignant pleural or ascites;
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Patients with leptomeningeal metastasis or uncontrolled brain;
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Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides.
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Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.
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Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment.
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The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
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Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Zhejiang Cancer Hospital
Investigators
- Principal Investigator: Xiaojing Lai, Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-TRT-SCLC-IIT