Non Small Cell Lung CancerPhase 1/2NCT05588206
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
A Phase 1/2 study testing Hypofractionated Stereotactic Radiotherap in people with Non Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Brain Metastases
- What is being tested?
- Hypofractionated Stereotactic Radiotherap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Age of 18-75 years old
- Patients must be able to undergo contrast enhanced MRI for planning
- Adequate bone marrow and organ function
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kaicheng Pan
Hangzhou, 310000
Kaicheng Pan, 057156006382, 15732192994@163.com
About this study
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
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.
Read the 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.
- Being tested
- Hypofractionated Stereotactic Radiotherap
- Keywords
- lung cancer, Brain Metastases, Hypofractionated Stereotactic Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Stereotactic RadiotherapRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Stereotactic Radiotherapy for Brain Metastases | Experimental | Not described Receives: Radiation: Hypofractionated Stereotactic Radiotherap |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
maximum tolerated dose
Measured: 1 years
Secondary outcomes (3)
ARE
adverse radiation effect
Measured: 2 years
iPFS
intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death
Measured: 2 years
OS
overall survival (OS) intervals from treatment to death or last follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588206
- Sponsor's protocol ID
- DeHSRT
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05588206
- Acronym / sponsor ID
- DeHSRT
- Keywords
- lung cancer, Brain Metastases, Hypofractionated Stereotactic Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Hangzhou Cancer Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Stereotactic Radiotherapy for Brain Metastases | Experimental | Radiation: Hypofractionated Stereotactic Radiotherap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Stereotactic RadiotherapA 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. | Radiation | Hypofractionated Stereotactic Radiotherapy for Brain Metastases |
Primary outcome
MTD
Time frame: 1 years
maximum tolerated dose
3 secondary outcomes
ARE
Time frame: 2 years
iPFS
Time frame: 2 years
OS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypofractionated Stereotactic Radiotherap in people with Non Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Xia (057156006382, bingxia_hzch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.