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This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI Arm | Active Comparator | Patients received PCI (recommended hippocampal protection) within 6 weeks after first-line treatment, with a total dose of 25 Gy, 2.5 Gy each time, once a day, 5 times a week, a total of 10 times. Brain enhancement MRI examination is performed every 3 months in first two years, and then performed every 6 months until the brain metastasis occur. |
|
| MRI Arm | Experimental | Patients undergo enhancement MRI examination every 3 months in first two years, and then performed every 6 months until the brain metastasis occur. Once brain metastases occur, brain radiotherapy and systemic treatment should be conducted with the follow-up observation of brain enhancement MRI continuing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Surveillance | Other | Receive MRI surveillance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | To compare the efficacy of PCI and MRI surveillance in patients with LS-SCLC. | From date of randomization until the date of death due to any cause, assessed up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year overall survival rate (1y-OS%) | Rate of patients surviving at 1 year. | 1-year |
| 3-year overall survival rate (3y-OS%) | Rate of patients surviving at 3 year. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with extensive SCLC (Appendix 2)ï¼›
The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groupsï¼›
During the 5 years before the start of the study, patients with malignant tumors other than SCLC, diseases with negligible risk of metastasis or death (such as expected 5-year OS > 90%) and malignant tumors expected to be cured (such as fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated by curable surgery, ductal carcinoma in situ treated by curable surgery)ï¼›
Previous head and neck radiation fields overlapped with PCI fieldï¼›
MRI examination contraindicated
There is evidence that significantly uncontrolled concomitant disease may affect the compliance of the study program, including severe liver disease (such as liver cirrhosis), uncontrollable major seizures or superior vena cava syndromeï¼›
Major cardiovascular diseases, myocardial infarction or cerebrovascular events within 3 months before randomization, unstable arrhythmias, or unstable angina pectorisï¼›
--Patients with known coronary artery disease, congestive heart failure that do not meet the above criteria, or left ventricular ejection fraction ((LVEF)) < 50% must receive a stable treatment plan and optimize it according to the advice of the attending physician, and consult a cardiologist if necessary。
Stroke (including hemorrhagic and ischemic) or transient ischemic attack occurred within 6 months before enrollmentï¼›
There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before entering the group, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis or vasculitisï¼›
Serious arteriovenous thrombosis events occurred within 3 months before enrollment, such as deep venous thrombosis, pulmonary embolism, etc. (except for implantable venous infusion port, catheter-derived thrombosis or superficial venous thrombosis, these conditions are not considered "severe" thromboembolism);
Diabetic ketoacidosis or hyperglycemia and hyperosmosis occurred in the past 6 months;
There was a history of hypertensive crisis and hypertensive encephalopathy;
Any other disease, metabolic disorder, abnormal result of physical examination or laboratory examination, and there is reason to suspect that it may affect the reliability of the results of the study or put the patient at high risk of treatment complicationsï¼›
The results of HIV test is positive
--All patients must be tested for HIV; patients with positive results of HIV will be excluded.
Major surgery has been performed within 28 days before the start of the study treatment, or major surgery is expected to be performed during the study period (except those for diagnostic purposes)ï¼›
Severe infections occur at the beginning of the study, including, but not limited to, infectious complications requiring hospitalization, bacteremia, or severe pneumoniaï¼›
Pregnant or lactating womenï¼›
Previous history of severe neurological or mental disorders, including epilepsy, dementia or severe depression that interfere with assessment;
The researchers believe that some conditions of the patients may affect the evaluation of the efficacy of this study, as well as the compliance of patients with this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinming Yu, PhD | Contact | +8613806406293 | sdyujinming@126.com | |
| Xiangjiao Meng, PhD | Contact | +8613793150996 | mengxiangjiao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, PhD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital and Institute | Recruiting | Jinan | Shandong | 250117 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146945 | Derived | Schneiders FL, Senan S. New strategies for patients with limited-stage small-cell lung cancer. Lancet Respir Med. 2024 Oct;12(10):748-750. doi: 10.1016/S2213-2600(24)00223-6. Epub 2024 Aug 12. No abstract available. |
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| Prophylactic Cranial Irradiation | Radiation | Receive PCI |
|
|
| 3-year |
| Progression-free survival (PFS) | From the date of randomization until the date of the first onset of disease progression or the time to die of any cause, whichever occurs first, assessed up to 2 years. |
| Brain metastasis rate | To compare brain metastasis rate between the two arms. | From the date of randomization until the date of occurrence of brain metastasis, assessed up to 2 years. |
| Cumulative incidence of neurocognitive impairment | To compare the neurocognitive toxicities of PCI and MRI surveillance in patients with LS-SCLC. | From the date of randomization until the date of occurrence of neurocognitive impairment , assessed up to 2 years. |
| Shandong Cancer Hospital | Recruiting | Jinan | China |
|
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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