Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer

Study Purpose

The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

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 and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Histology confirmed that it was non-small cell lung cancer.

- 1 to 10 brain metastases detected by magnetic resonance imaging (MRI) - A life expectancy of >3 months according to the DS GPA.

- KPS ≥70.

- Control of the primary lesions (thorax) at the time of SBRT.

- 2cm

- Age of 18-75 years old.

- Patients must be able to undergo contrast enhanced MRI for planning.

- Adequate bone marrow and organ function.

Exclusion Criteria:

- other malignant tumors.

- Prior surgery to brain metastasis.

- Prior brain radiotherapy.

- Non-small cell lung cancer with more than 10 brain metastases detected by MRI.

- Contraindication to receiving radiotherapy.

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.	NCT05588206
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 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	First People's Hospital of Hangzhou
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.	Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Brain Metastases

Additional Details

Arms & Interventions

Arms

Experimental: Hypofractionated Stereotactic Radiotherapy for Brain Metastases

Interventions

Radiation: - Hypofractionated Stereotactic Radiotherap

A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy.

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