Stage IV EGFR Mutated NSCL With Brain MetastasesPhase 3HybridNCT02882984
Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)
A Phase 3 study testing Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib, WBRT and HFSRS in people with Stage IV EGFR Mutated NSCL With Brain Metastases, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stage IV EGFR Mutated NSCL With Brain Metastases
- What is being tested?
- Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib, WBRT and HFSRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 4 cm.
- Positive EGFR mutation.
- Life expectancy ≥3months.
- Have one or more measurable encephalic lesions according to RECIST.
Show all 12Show fewer
- 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.
- Female subjects should not be pregnant.
- All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Written informed consent provided.
Who cannot join
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- Allergic to Icotinib.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Pregnancy or breast-feeding women.
- Participate in the other anti-tumor clinical trials in 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan PPH, Cancer Center
Chengdu, Sichuan, 710062
Yifeng Bai, MD PhD, 18183298718, 15756285949@qq.com
Ming zeng, MD PhD, 008617708131336, miller2002@yahoo.com
About this study
Official title: Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases
A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive function, quality of life (QoL) and adverse events.
Read the detailed description
WBRT remains to be standard of care for NSCL patients. Long term survival from WBRT may have noticeable cognitive dysfunction. The EGFR TKI has reasonable control for intracranial disease, but the duration of EGFR TKI control disease is variable due to tendency of drug resistance. To maintain intracranial disease control and improve cognitive function, the investigators propose using hypofractionated SRS in multiple brain metastases or large brain lesions alone with TKI.
- Being tested
- Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib, WBRT, HFSRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/IcotinibDrug
Also called EGFR-TKI
radiation given along with one of kind TKI
WBRTRadiation
3750 cGy in 15 fractions given within 3 weeks time.
HFSRSRadiation
All HFSRS given in 5 fractions. dose per fraction ranges from 5 to 8 Gy depending on the target volume and organs at risk tolerance.
| Study group | Role | What they receive |
|---|---|---|
| WBRT along with TKI | Active comparator | Drug: EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Tarceva/Icotinib
Radiation: whole brain radiotherapy
3750Gy/15F
Other Name: WBRT Receives: Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib; Radiation: WBRT |
| HFSRS with EGFR TKI | Experimental | Drug: EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Tarceva/Icotinib
Radiation: whole brain radiotherapy
25 to 40 Gy/5F
Other Name: HFSRS Receives: Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib; Radiation: HFSRS |
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 (2)
cognitive function
Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination
Measured: 18 month
Overall survival (OS)
Overall survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV EGFR Mutated NSCL With Brain MetastasesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ming zeng, MD, Sichuan Provincial People's Hospital
- Investigators
- Ming Zeng, MD PhD, Study chair, Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882984
- Sponsor's protocol ID
- Hybrid
- Acronym
- Hybrid
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases
- ClinicalTrials.gov ID
- NCT02882984
- Acronym / sponsor ID
- Hybrid / Hybrid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Aug 2016 (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.
A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive function, quality of life (QoL) and adverse events.
Detailed description
WBRT remains to be standard of care for NSCL patients. Long term survival from WBRT may have noticeable cognitive dysfunction. The EGFR TKI has reasonable control for intracranial disease, but the duration of EGFR TKI control disease is variable due to tendency of drug resistance. To maintain intracranial disease control and improve cognitive function, the investigators propose using hypofractionated SRS in multiple brain metastases or large brain lesions alone with TKI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBRT along with TKI | Active comparator | Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib, Radiation: WBRTDrug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 3750Gy/15F Other Name: WBRT |
| HFSRS with EGFR TKI | Experimental | Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib, Radiation: HFSRSDrug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 25 to 40 Gy/5F Other Name: HFSRS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 4 cm.
- Positive EGFR mutation.
- Life expectancy ≥3months.
Key exclusion criteria (6 listed)
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- Allergic to Icotinib.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Pregnancy or breast-feeding women.
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 |
|---|---|---|
| Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/IcotinibAlso: EGFR-TKIradiation given along with one of kind TKI | Drug | HFSRS with EGFR TKI, WBRT along with TKI |
| WBRT3750 cGy in 15 fractions given within 3 weeks time. | Radiation | WBRT along with TKI |
| HFSRSAll HFSRS given in 5 fractions. dose per fraction ranges from 5 to 8 Gy depending on the target volume and organs at risk tolerance. | Radiation | HFSRS with EGFR TKI |
Primary outcome
iPFS
Time frame: 18 months
intracranial progression-free survival
2 secondary outcomes
cognitive function
Time frame: 18 month
Overall survival (OS)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: Undecided
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.
Ming Zeng, MD PhD study chair
Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib, WBRT and HFSRS in people with Stage IV EGFR Mutated NSCL With Brain Metastases, run by Sichuan Provincial People's 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 12 inclusion and 6 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 30 Aug 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YiFeng Bai, MD PhD (008618183298718, 15756285949@qq.com), or a site near the patient. 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?
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 30 Aug 2016.