Brain MetastasesPhase 3NCT01535209
Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
A Phase 3 study testing stereotactic body radiotherapy (SBRT) and Whole-Brain Radiotherapy (WBRT) in people with Brain Metastases, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- stereotactic body radiotherapy (SBRT) and Whole-Brain Radiotherapy (WBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2012to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with surgically removed histologically proven metastatic cancer
- Subtotal or total resection of single brain metastasis
- Presence of single brain metastasis in MRI
- Karnofsky Performance Status ≥ 70
- Life expectancy > 6 months (minimal extracranial disease or availability of effective oncology treatment)
- No previous history of cranial irradiation
Show all 10Show fewer
- Availability of MRI
- Starting radiotherapy within six weeks after neurosurgery
- Negative pregnancy test for woman
- Written informed consent
Who cannot join
- Dementia and central nervous system diseases leading to higher risk of radiation toxicity
- Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
- Altered level of consciousness
- Histologically proven metastatic small cell lung cancer
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
M.Sklodowska-Curie Memorial Cancer Centre
Warsaw, 02-781
Lucyna Kepka, Prof., +48226439287, lucynak@coi.waw.pl
Lucyna Kepka, Prof.
About this study
Official title: Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.
Read the detailed description
Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.
- Conditions
- Brain Metastases
- Being tested
- stereotactic body radiotherapy (SBRT), Whole-Brain Radiotherapy (WBRT)
- Keywords
- Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiotherapy (SBRT)Radiation
Also called stereotactic body radiotherapy
18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter
Whole-Brain Radiotherapy (WBRT)Radiation
Also called whole brain irradiation, adjuvant cranial irradiation
10 x 3 Gy to whole brain
| Study group | Role | What they receive |
|---|---|---|
| SBRT to resection cavity | Experimental | 18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter Receives: Radiation: stereotactic body radiotherapy (SBRT) |
| WBRT | Active comparator | 30Gy in 10 fractions over 12 days to whole brain Receives: Radiation: Whole-Brain Radiotherapy (WBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival
Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.
Measured: 5 months after radiotherapy
Secondary outcomes (4)
Overall survival
Measured: 2 years
Quality of life assessment
Measured: 2 years
Time to distant intracranial progression
Measured: 2 years
Time to local progression
Time to progression in the irradiated cavity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Lower Silesian Oncology Center, Copernicus Memorial Hospital, Prof. Franciszek Lukaszczyk Memorial Oncology Center
- Responsible party
- Sponsor
- Investigators
- Lucyna Kepka, Prof., Principal investigator, M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535209
- Sponsor's protocol ID
- CAVITY
- Status last verified
- Feb 2012
- First submitted
- 14 Feb 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
- ClinicalTrials.gov ID
- NCT01535209
- Acronym / sponsor ID
- CAVITY
- Conditions
- Brain Metastases
- Keywords
- Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Lower Silesian Oncology Center, Copernicus Memorial Hospital, Prof. Franciszek Lukaszczyk Memorial Oncology Center
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Feb 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.
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.
Detailed description
Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT to resection cavity | Experimental | Radiation: stereotactic body radiotherapy (SBRT)18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter |
| WBRT | Active comparator | Radiation: Whole-Brain Radiotherapy (WBRT)30Gy in 10 fractions over 12 days to whole brain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with surgically removed histologically proven metastatic cancer
- Subtotal or total resection of single brain metastasis
- Presence of single brain metastasis in MRI
- Karnofsky Performance Status ≥ 70
- Life expectancy > 6 months (minimal extracranial disease or availability of effective oncology treatment)
Key exclusion criteria (4 listed)
- Dementia and central nervous system diseases leading to higher risk of radiation toxicity
- Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
- Altered level of consciousness
- Histologically proven metastatic small cell lung cancer
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 |
|---|---|---|
| stereotactic body radiotherapy (SBRT)Also: stereotactic body radiotherapy18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter | Radiation | SBRT to resection cavity |
| Whole-Brain Radiotherapy (WBRT)Also: whole brain irradiation, adjuvant cranial irradiation10 x 3 Gy to whole brain | Radiation | WBRT |
Primary outcome
Failure-free survival
Time frame: 5 months after radiotherapy
Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.
4 secondary outcomes
Overall survival
Time frame: 2 years
Quality of life assessment
Time frame: 2 years
Time to distant intracranial progression
Time frame: 2 years
Time to local progression
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
Lucyna Kepka, Prof. principal investigator
M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland
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 stereotactic body radiotherapy (SBRT) and Whole-Brain Radiotherapy (WBRT) in people with Brain Metastases, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 10 inclusion and 4 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 17 Feb 2012. 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 Poland. 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 Wojciech Michalski, M.S. (+48226433909, W.Michalski@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (time frame: 5 months after radiotherapy). 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 17 Feb 2012.