Brain MetastasisPhase 3BRAINNCT01724801
Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer
A Phase 3 study testing whole brain radiation(WBI) and Icotinib in people with Brain Metastasis and Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 2 sites in China.
Trial summary
EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with EGFR-mutant non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastasis, Non Small Cell Lung Cancer
- What is being tested?
- whole brain radiation(WBI) and Icotinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesChina
- Study dates
- 14 Oct 2012to 14 Sep 2016
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology.
- Patient who brain metastases was shown in MRI or CT scan. Brain metastases lesions should be more than 3.The diameter among these lesions should be more than 1 centimeter.
- Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group(ECOG) performance status 0-1. Life expectancy ≥12 weeks. The therapy of surgery,chemotherapy,radiotherapy that the patients were ever received should be more than 2 weeks ago.The patient had recovered from the treatment.
- Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Written informed consent provided.
Who cannot join
- Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
- Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
- Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
- Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
Show all 11Show fewer
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )< 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment.
- Patient need increase irradiation dose after routine irradiation(30GY/10f/2w) Patient should treat extra cranial lesions first. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
About this study
Official title: Phase III Study of Icotinib Treat the Patient With Brain Metastasis EGFR-mutant Non Small Cell Lung Cancer Comparing With Whole Brain Radiotherapy
EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with EGFR-mutant non-small cell lung cancer.
Read the detailed description
no available
- Conditions
- Brain Metastasis, Non Small Cell Lung Cancer
- Being tested
- whole brain radiation(WBI), Icotinib
- Keywords
- EGFR mutant
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole brain radiation(WBI)Radiation
WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles
IcotinibDrug
administered orally at a dose of 125 mg 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| icotinib | Experimental | icotinib administered orally at a dose of 125 mg 3 times daily Receives: Drug: Icotinib |
| Whole brain irradiation | Active comparator | Whole brain irradiation 30Gy/3Gy/10 fractions plus concurrent or sequential chemotherapy for 4-6 cycles Receives: Radiation: whole brain radiation(WBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
iPFS
intracranial progression-free survival
Measured: 18 months
Secondary outcomes (5)
progress-free survival (PFS)
progress-free survival
Measured: up to 16 months
time of controlling brain metastasis symptom
time of controlling brain metastasis symptom
Measured: 18months
Response rate of brain metastasis
Response rate of brain metastasis
Measured: 12months
Cognitive function
Cognitive function
Measured: 18months
overall survival(OS)
overall survival(OS)
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study start14 Oct 2012
- Primary completion30 Jun 2015
- Study completion14 Sep 2016
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 Brain MetastasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jinji Yang, MD, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724801
- Sponsor's protocol ID
- CTONG1201
- Acronym
- BRAIN
- Status last verified
- Feb 2017
- First submitted
- 14 Oct 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Yang JJ, Zhou C, Huang Y, Feng J, Lu S, Song Y, Huang C, Wu G, Zhang L, Cheng Y, Hu C, Chen G, Zhang L, Liu X, Yan HH, Tan FL, Zhong W, Wu YL. Icotinib versus whole-brain irradiation in patients with EGFR-mutant non-small-cell lung cancer and multiple brain metastases (BRAIN): a multicentre, phase 3, open-label, parallel, randomised controlled trial. Lancet Respir Med. 2017 Sep;5(9):707-716. doi: 10.1016/S2213-2600(17)30262-X. Epub 2017 Jul 19.
PubMed 28734822
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Icotinib Treat the Patient With Brain Metastasis EGFR-mutant Non Small Cell Lung Cancer Comparing With Whole Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT01724801
- Acronym / sponsor ID
- BRAIN / CTONG1201
- Conditions
- Brain Metastasis, Non Small Cell Lung Cancer
- Keywords
- EGFR mutant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Study start
- 14 Oct 2012
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 12 Nov 2012 (estimated)
- 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.
EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with EGFR-mutant non-small cell lung cancer.
Detailed description
no available
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| icotinib | Experimental | Drug: Icotinibicotinib administered orally at a dose of 125 mg 3 times daily |
| Whole brain irradiation | Active comparator | Radiation: whole brain radiation(WBI)Whole brain irradiation 30Gy/3Gy/10 fractions plus concurrent or sequential chemotherapy for 4-6 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology.
- Patient who brain metastases was shown in MRI or CT scan. Brain metastases lesions should be more than 3.The diameter among these lesions should be more than 1 centimeter.
- Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group(ECOG) performance status 0-1. Life expectancy ≥12 weeks. The therapy of surgery,chemotherapy,radiotherapy that the patients were ever received should be more than 2 weeks ago.The patient had recovered from the treatment.
- Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Key exclusion criteria (11 listed)
- Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
- Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
- Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
- Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
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 |
|---|---|---|
| whole brain radiation(WBI)WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles | Radiation | Whole brain irradiation |
| Icotinibadministered orally at a dose of 125 mg 3 times daily | Drug | icotinib |
Primary outcome
iPFS
Time frame: 18 months
intracranial progression-free survival
5 secondary outcomes
progress-free survival (PFS)
Time frame: up to 16 months
time of controlling brain metastasis symptom
Time frame: 18months
Response rate of brain metastasis
Time frame: 12months
Cognitive function
Time frame: 18months
overall survival(OS)
Time frame: 24months
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 1 Mar 2017.
- Derived from this study: PubMed 28734822Yang JJ, Zhou C, Huang Y, Feng J, Lu S, Song Y, Huang C, Wu G, Zhang L, Cheng Y, Hu C, Chen G, Zhang L, Liu X, Yan HH, Tan FL, Zhong W, Wu YL. Icotinib versus whole-brain irradiation in patients with EGFR-mutant non-small-cell lung cancer and multiple brain metastases (BRAIN): a multicentre, phase 3, open-label, parallel, randomised controlled trial. Lancet Respir Med. 2017 Sep;5(9):707-716. doi: 10.1016/S2213-2600(17)30262-X. Epub 2017 Jul 19.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Metastasis
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast 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.
Jinji Yang, MD study director
Guangdong Provincial People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing whole brain radiation(WBI) and Icotinib in people with Brain Metastasis and Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 2 sites 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 6 inclusion and 11 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
iPFS (time frame: 18 months). 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 NCT01724801, 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 1 Mar 2017.