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Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis

Study Purpose

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Small cell carcinoma of lung.
  • - Intracranial metastases needed surgical decompression.
  • - Patients with contraindications for MRI.
  • - Previous radiotherapy or excision for intracranial metastases.
  • - 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) - Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.
  • - Urine protein 3-4+, or 24h urine protein quantitative >1g.
  • - Severe uncontrolled disease.
  • - Uncontrollable seizure or psychotic patients without self-control ability.
  • - Women in pregnancy, lactation period.
- Other not suitable conditions determined by the investigators

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06582940
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 MRI-guided Adaptive Radiotherapy, Non-small Cell Lung Cancer, Brain Metastasis
Additional Details

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for NSCLC patients with brain metastasis. In this study, patients will be randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (SRT) (without PTV expansion margin), while patients in the control group will receive CT-guided conventional standard SRT (with PTV expansion margin). After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.

Arms & Interventions

Arms

Experimental: The study group

Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The MRI-linac is used for the delivery of radiotherapy.

Active Comparator: The control group

Patients in the study group will receive conventional standard stereotactic radiotherapy (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The conventional linac is used for the delivery of radiotherapy.

Interventions

Radiation: - MRI-guided adaptive SRT

MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired.

Radiation: - Conventional SRT

Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060

Site Contact

Hui Liu, MD

[email protected]

+86-020-87343031

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