Stereotactic Body Radiation TherapyPhase 2Rvision-001NCT04147728
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases With Perilesional Edema in NSCLC
A Phase 2 study testing Anlotinib and Stereotactic Radiosurgery in people with 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 is safe, effective in the treatment of limited brain metastases with Perilesional edema in non-small cell lung cancer. 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 and Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2019to 15 Dec 2022
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in this study, signed informed consent.
- 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;
- Female patients should agree to use contraceptives during and within 6 months after the study.
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；
- Patients who still can't tolerate SRS after anlotinib treatment, even after adding mannitol, and have to receive steroid treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
Beijing, Beijing Municipality, 100191
Hongqing Zhuang, Doctor, 13051776232, hongqingzhuang@163.com
Yuxia Wang, Doctor, 15001292991, lily31415926@126.com
About this study
Official title: Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases With Perilesional Edema in Non-small Cell Lung Cancer：An Exploratory Single-Arm Phase II Clinical Trail
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with Perilesional edema in non-small cell lung cancer.
Read the detailed description
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with perilesional edema in non-small cell lung cancer. The sample size is 50. Patients start to take Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, day22~36.Edema index will be used to evaluate the effectiveness of Anlotinib. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.
- Conditions
- Stereotactic Body Radiation Therapy
- Being tested
- Anlotinib, Stereotactic Radiosurgery
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 RadiosurgeryRadiation
Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases
| Study group | Role | What they receive |
|---|---|---|
| SRS Combination With Anlotinib | Experimental | Stereotactic Radiosurgery Combination With Anlotinib Receives: Drug: Anlotinib; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
EI
Edema Index. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.
Measured: 1 month
Secondary outcomes (7)
PFS
Progression-free Survival
Measured: 1 year
OS
Overall Survival
Measured: 1 year
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
SRS rate
the rate of SRS after anlotinib treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start24 Dec 2019
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Tianjin Medical University
- Responsible party
- Sponsor
- Investigators
- Hongqing Zhuang, doctor, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147728
- Sponsor's protocol ID
- Rvision-001
- Acronym
- Rvision-001
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhuang H, Wang Y, Cheng C, Shi S. The efficacy of anlotinib instead of glucocorticoids for edema induced by brain metastases in NSCLC patients with anti-PD1/PDL-1 immunotherapy. Neuro Oncol. 2021 Jan 30;23(1):169-171. doi: 10.1093/neuonc/noaa236. No abstract available.
PubMed 33294918
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases With Perilesional Edema in Non-small Cell Lung Cancer：An Exploratory Single-Arm Phase II Clinical Trail
- ClinicalTrials.gov ID
- NCT04147728
- Acronym / sponsor ID
- Rvision-001 / Rvision-001
- Conditions
- Stereotactic Body Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Huashan Hospital, Tianjin Medical University
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 1 Nov 2019 (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 is safe, effective in the treatment of limited brain metastases with Perilesional edema in non-small cell lung cancer.
Detailed description
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with perilesional edema in non-small cell lung cancer. The sample size is 50. Patients start to take Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, day22~36.Edema index will be used to evaluate the effectiveness of Anlotinib. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRS Combination With Anlotinib | Experimental | Drug: Anlotinib, Radiation: Stereotactic RadiosurgeryStereotactic Radiosurgery Combination With Anlotinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients voluntarily participate in this study, signed informed consent.
- 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 (15 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. | Drug | SRS Combination With Anlotinib |
| Stereotactic RadiosurgeryStereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases | Radiation | SRS Combination With Anlotinib |
Primary outcome
EI
Time frame: 1 month
Edema Index. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.
7 secondary outcomes
PFS
Time frame: 1 year
OS
Time frame: 1 year
ORR
Time frame: 3 months
DCR
Time frame: 3 months
iORR
Time frame: 3 months
iPFS
Time frame: 3 months
SRS rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 33294918Zhuang H, Wang Y, Cheng C, Shi S. The efficacy of anlotinib instead of glucocorticoids for edema induced by brain metastases in NSCLC patients with anti-PD1/PDL-1 immunotherapy. Neuro Oncol. 2021 Jan 30;23(1):169-171. doi: 10.1093/neuonc/noaa236. No abstract available.
- 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.
Hongqing Zhuang, doctor study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib and Stereotactic Radiosurgery in people with 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 7 inclusion and 15 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 4 Mar 2020. 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 phase mean?
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 Hongqing Zhuang, doctor (13051776232, hongqingzhuang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EI (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147728, which also lists 1 linked publication.
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 4 Mar 2020.