Back to resultsDose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Brain Metastases
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hypofractionated Stereotactic Radiotherap
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring lung cancer, Brain Metastases, Hypofractionated Stereotactic Radiotherapy
Eligibility 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<Tumor size ≤ 4 cm
- 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.
Sites / Locations
- Kaicheng PanRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypofractionated Stereotactic Radiotherapy for Brain Metastases
Arm Description
Outcomes
Primary Outcome Measures
MTD
maximum tolerated dose
Secondary Outcome Measures
ARE
adverse radiation effect
iPFS
intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death
OS
overall survival (OS) intervals from treatment to death or last follow-up
Full Information
NCT ID
NCT05588206
First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
First People's Hospital of Hangzhou
Collaborators
Hangzhou Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05588206
Brief Title
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
Official Title
Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First People's Hospital of Hangzhou
Collaborators
Hangzhou Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Brain Metastases
Keywords
lung cancer, Brain Metastases, Hypofractionated Stereotactic Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated Stereotactic Radiotherapy for Brain Metastases
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Stereotactic Radiotherap
Intervention Description
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.
Primary Outcome Measure Information:
Title
MTD
Description
maximum tolerated dose
Time Frame
1 years
Secondary Outcome Measure Information:
Title
ARE
Description
adverse radiation effect
Time Frame
2 years
Title
iPFS
Description
intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death
Time Frame
2 years
Title
OS
Description
overall survival (OS) intervals from treatment to death or last follow-up
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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<Tumor size ≤ 4 cm
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Xia
Phone
057156006382
Email
bingxia_hzch@163.com
Facility Information:
Facility Name
Kaicheng Pan
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaicheng Pan
Phone
057156006382
Email
15732192994@163.com
12. IPD Sharing Statement
Learn more about this trial
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
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