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Phase II Study for WBRT Versus Endostatin Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Small-cell Lung Cancer: a Single-centre, Open-label, Randomised Controlled Trial

Phase II Study for WBRT Versus Endostatin Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Small-cell Lung Cancer: a Single-centre, Open-label, Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020685
Enrollment
Unknown
Registered
2019-01-13
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Interventions

Group 2:Whole Brain Radiotherapy+Endosatin

Sponsors

Department of Oncology, Sanming First Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. the pathological diagnosis of small cell lung cancer 2. enhanced MRI showed brain metastases = 2 or NSCLC of brain metastases after resection of residual lesions in = 2 / intracranial metastases in patients with new; 3. Aged 18-80 years old; 4. expected survival period over 2 months; 5. no contraindications of radiotherapy 6. If previously used bevacizumab, stop taking it at least 4 weeks before WBRT; 7. KPS score = 70; 8.GPA score 0.5 - 3.5; 9. a week before randomization, bone marrow and liver and kidney function in patients with meet the following criteria: HB = 100, g/L = 1.5 × 10^9/L neutrophil and platelet = 100 × 10^9/L; total bilirubin = 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 1.5 times the upper limit of normal; more than 1.5 times the upper limit of normal serum creatinine or creatinine clearance rate = 60 ml/min, urea N = 200mg/L; Urine dipstick testing the proteinuria < 1+; if the urine dipstick test value, 1+, is 24 hours total urine protein must < 500mg; 10. compliance research plan and follow-up process, and be able to carry out oral therapy; 11. can understand and consent.

Exclusion criteria

Exclusion criteria: 1. The patient had received radiotherapy and was allergic to Endosatin; 2. If SCLC is the second primary tumor, the first primary tumor does not progress for at least 5 years; 3. The patients received thalidomide treatment 4 weeks before entering the study group; 4. According to the researchers, there is a serious risk to the safety of patients or affect the patient to complete the study with disease, and patient compliance is different; 5. With or without chronic cough, sputum, dyspnea, interstitial lung disease activity, pulmonary function test (FEV1/FVC<), any moderate or severe chronic obstructive pulmonary disease (COPD) FEV1/FVC<70%;FEV1<80%) with or without chronic cough, sputum and dyspnea 70% FEV1 & LTR 80% estimate, Diffuse carbon monoxide lung volume DLCO<40%, high-resolution CT displays diffuse interstitial lung disease (DIPD) and other researchers determined; 6. On gastrointestinal physiology is not perfect, or absorption disorder syndrome, or can not tolerate oral drugs, or peptic ulcer active; 7. Any unstable system disease including active infection, hypertension, unstable angina, congestive heart failure within 3 months of angina attack, myocardial infarction in this group before 6 months; Drug therapy for severe mental disorders, liver, kidney or metabolic diseases; mental / psychiatric disorders, such as Alzheimer's disease; 8. Can not completely control eye inflammation or eye infection, or any possible cause of eye disease; 9. Suffering from immunodeficiency disease or other acquired, congenital immunodeficiency disease, or has a history of organ transplantation; 10. Any disease, metabolic disorder, or laboratory examination or suspected or treated complication in a patient is at high risk of medication.

Design outcomes

Primary

MeasureTime frame
iPFS;

Countries

China

Contacts

Public ContactLifeng Zhu

Department of Oncology, Sanming First Hospital of Fujian Medical University

zhulfsm@163.com+86 13850801216

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026