Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

  • STATUS
    Recruiting
  • End date
    Apr 15, 2028
  • participants needed
    534
  • sponsor
    Shandong Cancer Hospital and Institute
Updated on 10 May 2021

Summary

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.

Details
Condition Limited Stage Small Cell Lung Cancer, limited-stage small cell lung cancer
Treatment Prophylactic cranial irradiation, MRI Surveillance
Clinical Study IdentifierNCT04829708
SponsorShandong Cancer Hospital and Institute
Last Modified on10 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2)
Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST v1.1)
Brain MRI examination should be performed to exclude metastatic lesions of brain parenchyma and meninges within four weeks before enrollment
The ECOG PS score was 0~2
The interval between the end of the last treatment cycle and the randomized grouping should be no more than 8 weeks
Estimated survival time 12 weeks
Patients must agree to participate in the study, comply with the research plan and follow-up process. Written informed consent must obtained
Male or female aged18 and75 years old
For fertile women and man: Subjects are required to agree to maintain abstinence (no heterosexual intercourse) or use contraception with an annual failure rate of less than 1% during the study treatment period and within at least 6 months after the end of the study treatment period
Hematological indexes: absolute neutrophil count1.5109/ L, platelet count75109 /L, haemoglobin9.0g/dL, serum albumin3g/dL
Liver function: serum total bilirubin level1.5 times normal upper limit (ULN), glutamic pyruvic transaminase, glutamic oxaloacetic transaminase and alkaline phosphatase2.5 times ULN
Renal function: defined as serum creatinine 1.5 times ULN or calculated creatinine clearance 15ml/min (Cockcroft-Gault formula, Appendix 4); urinary protein negative or less than 2g in routine urine examination, or 24-hour urinary protein < 1g
Good clotting function, defined as international standardized ratio (INR) or prothrombin time (PT) 1.5x ULN;. If the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant use
Women of childbearing age must undergo a urinary pregnancy test within 7 days before the start of treatment and the results are negative and are not breastfeeding

Exclusion Criteria

Patients with extensive SCLC (Appendix 2)
The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groups
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)
Previous head and neck radiation fields overlapped with PCI field
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 syndrome
Major cardiovascular diseases, myocardial infarction or cerebrovascular events within 3 months before randomization, unstable arrhythmias, or unstable angina pectoris
\--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 enrollment
\. 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 vasculitis
\. 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 complications
\. 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)
\. Severe infections occur at the beginning of the study, including, but not
limited to, infectious complications requiring hospitalization, bacteremia, or
severe pneumonia
\. Pregnant or lactating women
\. 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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