CancerPhase 2RadErNCT01518621
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
A Phase 2 study testing Radiation and Radiation plus erlotinib in people with Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Radiation and Radiation plus erlotinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- May 2012to 10 Dec 2018
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- More than 3 sites (organ systems) of extracranial metastases
- Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
- Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
Trial locations and contacts
1 site in 1 country.
About this study
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.
Read the detailed description
Endpoints
Primary:
- To determine if erlotinib given orally along with concurrent WBRT in lung cancer patients with brain metastases, improves median overall survival compared to those treated with WBRT alone.
Secondary:
- To confirm the safety profile of erlotinib along with concurrent WBRT, in the context of treating central nervous system malignancies.
- To evaluate if erlotinib along with concurrent WBRT increases local control rate as measured by MRI at 8 weeks, compared to WBRT alone.
- To evaluate if erlotinib along with concurrent WBRT increases time to neurologic progression of disease based on neuropsychological assessment at baseline, at 8 and 20 weeks after WBRT.
- To evaluate quality of life parameters in patients treated with WBRT alone vs concomitant erlotinib and WBRT
- To evaluate if mutation status has impact on the above mentioned parameters Trial design Open multicenter randomized phase II trial. Patients Patients > 18 years with histologically confirmed NSCLC and brain metastases verified on either CT or MRI, not eligible for neurosurgery or stereotactic radiation therapy.
Trial treatment Patients will be randomized 1:1 to either treatment arm A or B.
- Arm A: WBRT 3 Gy x10 alone.
- Arm B: WBRT 3 Gy x10 and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.
Number of patients 150 patients will be included, 75 in each arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Also called Whole brain radiation therapy
Whole brain radiation
Radiation plus erlotinibDrug
Also called Whole brain radiation therapy and tyrosin kinase inhibitor
Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy alone | Active comparator | Total brain irradiation, 3Gy x10 Receives: Radiation: Radiation |
| Radiation plus erlotinib | Experimental | Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation Receives: Drug: Radiation plus erlotinib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startMay 2012
- Primary completion10 Dec 2017
- Study completion10 Dec 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odd Terje Brustugun, Oslo University Hospital
- Investigators
- Odd Terje Brustugun, MD PhD, Principal investigator, Norwegian Radium Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518621
- Sponsor's protocol ID
- RadEr
- Acronym
- RadEr
- Status last verified
- Mar 2019
- First submitted
- 19 Jan 2012
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01518621
- Acronym / sponsor ID
- RadEr / RadEr
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 26 Jan 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.
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.
Detailed description
Endpoints
Primary:
- To determine if erlotinib given orally along with concurrent WBRT in lung cancer patients with brain metastases, improves median overall survival compared to those treated with WBRT alone.
Secondary:
- To confirm the safety profile of erlotinib along with concurrent WBRT, in the context of treating central nervous system malignancies.
- To evaluate if erlotinib along with concurrent WBRT increases local control rate as measured by MRI at 8 weeks, compared to WBRT alone.
- To evaluate if erlotinib along with concurrent WBRT increases time to neurologic progression of disease based on neuropsychological assessment at baseline, at 8 and 20 weeks after WBRT.
- To evaluate quality of life parameters in patients treated with WBRT alone vs concomitant erlotinib and WBRT
- To evaluate if mutation status has impact on the above mentioned parameters Trial design Open multicenter randomized phase II trial. Patients Patients > 18 years with histologically confirmed NSCLC and brain metastases verified on either CT or MRI, not eligible for neurosurgery or stereotactic radiation therapy.
Trial treatment Patients will be randomized 1:1 to either treatment arm A or B.
- Arm A: WBRT 3 Gy x10 alone.
- Arm B: WBRT 3 Gy x10 and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.
Number of patients 150 patients will be included, 75 in each arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy alone | Active comparator | Radiation: RadiationTotal brain irradiation, 3Gy x10 |
| Radiation plus erlotinib | Experimental | Drug: Radiation plus erlotinibTotal brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- More than 3 sites (organ systems) of extracranial metastases
- Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
- Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
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 |
|---|---|---|
| RadiationAlso: Whole brain radiation therapyWhole brain radiation | Radiation | Radiotherapy alone |
| Radiation plus erlotinibAlso: Whole brain radiation therapy and tyrosin kinase inhibitorRadiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation | Drug | Radiation plus erlotinib |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Odd Terje Brustugun, MD PhD principal investigator
Norwegian Radium 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 Radiation and Radiation plus erlotinib in people with Cancer, run by Oslo University Hospital at 1 site in Norway.
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 0 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Mar 2019. 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 Norway. 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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.
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 13 Mar 2019.