Stereotactic Body Radiation TherapyAnloSBRTNCT04912128
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC
An observational study of Stereotactic Body Radiation Therapy, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stereotactic Body Radiation Therapy
- What is being tested?
- Anlotinib
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2017to 1 Jun 2021
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: NSCLC patients with limited brain metastases who received stereotactic radiosurgery with or without Anlotinib treatment.
Who may be able to join
- Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;
- Patients aged between 18 -80 years; with expected survival time>3 months.
- Patients with no more than 5 brain metastases
- Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
- blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
Who cannot join
- Patients who had previously used antiangiogenic agents within 1 month;
- Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
- Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis;
- Patients with cerebral infarction and cerebral hemorrhage;
- Patients without perilesional edema；
- Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment.
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- Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);
- Patients with visceral dissemination or severe symptoms, which could cause death in short term;
- Patients with any other severe and/or uncontrolled disease;
- Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month;
- Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity;
- Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism;
- Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
- Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
Beijing, Beijing Municipality, 100191
About this study
Official title: Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.
Read the detailed description
This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.
- Conditions
- Stereotactic Body Radiation Therapy
- Being tested
- Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called Antiangiogenic agents
Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.
Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib group | Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. All patients received SBRT for brain metastases. Receives: Drug: Anlotinib | |
| SBRT group | Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 1 years
Secondary outcomes (5)
OS
overall survival
Measured: 1 years
ORR
objective response rate
Measured: 3 months
DCR
disease control rate
Measured: 3 months
iORR
intracranial objective response rate
Measured: 3 months
iPFS
intracranial progression-free survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Jan 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Tianjin Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912128
- Sponsor's protocol ID
- AnloSBRT
- Acronym
- AnloSBRT
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04912128
- Acronym / sponsor ID
- AnloSBRT / AnloSBRT
- Conditions
- Stereotactic Body Radiation Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Huashan Hospital, Tianjin Medical University
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 3 Jun 2021 (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 purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.
Detailed description
This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib group | – | Drug: AnlotinibPatients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. All patients received SBRT for brain metastases. |
| SBRT group | – | –Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients with limited brain metastases who received stereotactic radiosurgery with or without Anlotinib treatment.
Key inclusion criteria (5 listed)
- Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;
- Patients aged between 18 -80 years; with expected survival time>3 months.
- Patients with no more than 5 brain metastases
- Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
Key exclusion criteria (14 listed)
- Patients who had previously used antiangiogenic agents within 1 month;
- Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
- Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis;
- Patients with cerebral infarction and cerebral hemorrhage;
- Patients without perilesional edema；
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 |
|---|---|---|
| AnlotinibAlso: Antiangiogenic agentsAnlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret. Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases | Drug | Anlotinib group |
Primary outcome
PFS
Time frame: 1 years
progression-free survival
5 secondary outcomes
OS
Time frame: 1 years
ORR
Time frame: 3 months
DCR
Time frame: 3 months
iORR
Time frame: 3 months
iPFS
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stereotactic Body Radiation Therapy, run by Peking University Third Hospital 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 3 Jun 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (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 3 Jun 2021.