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NCT04946019CompletedPhase 2

MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer

A Prospective, Phase II Study of MR-Linac Guided Adaptive Fractionated Stereotactic Radiotherapy for Brain Metastases From Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 12 Dec 2024

Brief summary (registry, in English)

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
55 (actual)
First submitted
25 Jun 2021
Start date
1 Jun 2021
Primary completion date
17 Jul 2024
Lead sponsor
Sun Yat-sen University
Diseases
Lung cancer
NCT number
NCT04946019

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 55
  • From 1 Jun 2021 to the primary completion date, 17 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intracranial metastases needed surgical decompression
  • Previous radiotherapy or excision for intracranial metastases
  • Major surgery within 28 days or minor surgery or needle biopsy within 48 hours

Other illness

  • Bleeding tendency or coagulation disorder
  • Severe vascular disease occurred within 6 months
  • Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months
  • Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
  • Uncontrolled hypertension (systolic \> 150mmHg and/or diastolic \> 100mmHg)
  • Severe uncontrolled disease
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Other not suitable conditions determined by the investigators

Other

  • Small cell carcinoma of lung
  • Patients with contraindications for MRI
  • The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
  • A cavity over 2cm in diameter of primary tumor or metastasis
  • Hemoptysis (1/2 teaspoon blood/day) happened within 1 month
  • The use of full-dose anticoagulation within the past 1 month
  • Urine protein 3-4+, or 24h urine protein quantitative \>1g
  • Women in pregnancy, lactation period

Who the study is looking for

  • Aged 18-75 years
  • Histologically or cytologically confirmed non-small cell lung cancer
  • 1-10 metastases on contrast-enhanced MRI
  • Radiotherapy for extracranial lesions is permitted
  • Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of intracranial metastases during previous TKI therapy
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN
  • Informed-consent

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hui Liu
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.