MetastasesPhase 3NCT01169129
Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
A Phase 3 study testing surgery and radiosurgery in people with Metastases and Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Patients in good general condition with resectable brain metastases, looks better with more intense treatment of metastases. This local treatment has been accomplished with surgery or radiosurgery. However, there are no randomized studies comparing these two types of treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Metastases, Cancer
- What is being tested?
- surgery and radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Jul 2010
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histopathology of primary tumors: all but primary small cell cancer, germ cell tumors, leukemia, lymphoma, or primary central nervous system.
- Primary-site: controlled, meaning operated and / or irradiated; without detectable local tumor activity
- Lack of extra-cranial metastases
- Absence of prior brain irradiation
- Number of brain metastases: 1-3
- Location of brain metastases: brain regions eligible for surgery (non-eloquent areas) and RC (metastases with largest diameter ≤ 3 cm, volume <15 mL, and> 5 mm from the optic chiasm, optic nerves, thalamus, hypothalamus, basal ganglia base, optic tract, optic radiation, midbrain, pons, medulla, corpus callosum, internal capsule, hippocampus and amygdala, and <10 ml of brain tissue receiving ≥ 12 Gy).
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- Metastasis-that does not cause significant mass effect and hydrocephalus or herniation requiring urgent surgical intervention
- Second uncontrolled primary tumor site: none, except non-melanoma skin cancer
- Absence of comorbid conditions that prevents surgery for resection of brain metastases
- Absence of connective tissue disease such as lupus erythematosus or scleroderma
- Patients in chemotherapy need to have their chemotherapy treatment suspended.
- Patients must consent to be followed by clinical staff of the Barretos Cancer Hospital (HCB).
- KPS: ≥ 70%
- Neutrophils ≥ 1800 cells / mL until 14 days prior to study entry
- Platelets ≥ 100,000 cells / mL until 14 days prior to study entry
- Hemoglobin ≥ 10 g / dL 14 days prior to entering the study (transfusion is allowed to achieve required concentration)
- Creatinine ≤ 1.7 mg / dL 14 days prior to study entry
- BUN ≤ 30 mg / dL 14 days prior to entry on study
- Bilirubin ≤ 2 mg / dL 14 days prior to study entry
- TGO/TGP Up to three times normal on examination until 14 days prior to study entry Prothrombin time-INR <1.4 at examination until 14 days prior to study entry
- Systolic pressure ≤ 160 mm Hg and diastolic pressure ≤ 90 mm Hg at examination until 14 days prior to study entry Electrocardiogram-without acute myocardial infarction in examination until 14 days prior to study entry
- No active bleeding or pathological condition that entails high risk of bleeding
- Negative pregnancy test at least 14 days prior to study entry
- Informed Consent: The patient will be informed of the investigational nature of treatment and only enter the study after agreeing to participate in the study signed a consent form that informs the side effects and possible benefits and potential of both modalities treatment.
Who cannot join
- Metastasis in the posterior fossa, because this patient will be operated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study
Patients in good general condition with resectable brain metastases, looks better with more intense treatment of metastases. This local treatment has been accomplished with surgery or radiosurgery. However, there are no randomized studies comparing these two types of treatment. The purpose of this study is to make this.
Read the detailed description
Patients in good general condition with resectable 1-3 brain metastases will be randomized to surgery and whole brain radiotherapy and whole brain radiotherapy and radiosurgery. Initially we will evaluate the feasibility of carrying out the study with 15 patients in each arm, and after, we will follow with the primary end-point of comparing the toxicity of the exclusively radiotherapy arm with complications of the surgical arm. As a secondary end-point, we will evaluate local recurrence-free survival, overall survival, distance cerebral relapse-free survival (metachronous brain metastasis), free of neurological progression survival, free of neurological death survival, free of dependent life (another person)survival , steroid-free survival and quality of life.
- Conditions
- Metastases, Cancer
- Being tested
- surgery, radiosurgery
- Keywords
- brain metastases, radiosurgery, neurosurgery, surgery, radiotherapy, resectable brain metastases
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
Also called neurosurgery
resection of brain metastases
radiosurgeryRadiation
Also called stereotactic radiosurgery
radiosurgery to brain metastases
| Study group | Role | What they receive |
|---|---|---|
| surgery+whole-brain irradiation | Active comparator | brain metastases is resected and the patient is submitted to whole-brain irradiation Receives: Other: surgery |
| whole-brain irradiation+radiosurgery | Active comparator | patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery. Receives: Radiation: radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
One year after the start of patient recruitment, the study will be analyzed for feasibility and, if feasible, we will pursue the study with primary end-point of comparing the toxicity of exclusive radiation therapy arm with the surgical arm.
Measured: 1 year
Secondary outcomes (1)
complications and toxicity
One year after the start of patient recruitment, the study will be analyzed for toxicity of the radiotherapy arm versus the arm surgical complications, and if compatible, will continue the study until 70 patients in each arm.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo A Nakamura, MD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169129
- Sponsor's protocol ID
- 3602010
- Status last verified
- Feb 2014
- First submitted
- 22 Jul 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01169129
- Acronym / sponsor ID
- 3602010
- Conditions
- Metastases, Cancer
- Keywords
- brain metastases, radiosurgery, neurosurgery, surgery, radiotherapy, resectable brain metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Jul 2010 (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.
Patients in good general condition with resectable brain metastases, looks better with more intense treatment of metastases. This local treatment has been accomplished with surgery or radiosurgery. However, there are no randomized studies comparing these two types of treatment. The purpose of this study is to make this.
Detailed description
Patients in good general condition with resectable 1-3 brain metastases will be randomized to surgery and whole brain radiotherapy and whole brain radiotherapy and radiosurgery. Initially we will evaluate the feasibility of carrying out the study with 15 patients in each arm, and after, we will follow with the primary end-point of comparing the toxicity of the exclusively radiotherapy arm with complications of the surgical arm. As a secondary end-point, we will evaluate local recurrence-free survival, overall survival, distance cerebral relapse-free survival (metachronous brain metastasis), free of neurological progression survival, free of neurological death survival, free of dependent life (another person)survival , steroid-free survival and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery+whole-brain irradiation | Active comparator | Other: surgerybrain metastases is resected and the patient is submitted to whole-brain irradiation |
| whole-brain irradiation+radiosurgery | Active comparator | Radiation: radiosurgerypatients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Histopathology of primary tumors: all but primary small cell cancer, germ cell tumors, leukemia, lymphoma, or primary central nervous system.
- Primary-site: controlled, meaning operated and / or irradiated; without detectable local tumor activity
- Lack of extra-cranial metastases
- Absence of prior brain irradiation
- Number of brain metastases: 1-3
Key exclusion criteria (1 listed)
- Metastasis in the posterior fossa, because this patient will be operated.
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 |
|---|---|---|
| surgeryAlso: neurosurgeryresection of brain metastases | Other | surgery+whole-brain irradiation |
| radiosurgeryAlso: stereotactic radiosurgeryradiosurgery to brain metastases | Radiation | whole-brain irradiation+radiosurgery |
Primary outcome
feasibility
Time frame: 1 year
One year after the start of patient recruitment, the study will be analyzed for feasibility and, if feasible, we will pursue the study with primary end-point of comparing the toxicity of exclusive radiation therapy arm with the surgical arm.
1 secondary outcome
complications and toxicity
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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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.
Ricardo A Nakamura, MD principal investigator
Barretos Cancer Hospital
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 surgery and radiosurgery in people with Metastases and Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
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 24 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Feb 2014. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
feasibility (time frame: 1 year). 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 4 Feb 2014.