Neoplasm MetastasisPhase 2NCT00781209
The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
A Phase 2 study testing Irradiation plus Stereotactic Radiosurgery in people with Neoplasm Metastasis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Irradiation plus Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed malignant disease
- All primary tumors exclusive of:
- Small cell lung cancer
- Renal cell cancer (hypernephroma)
- Melanoma
- Sarcoma
Show all 11Show fewer
- 1-3 intraparenchymal metastases
- Age ≥18 years
- RPA(14) 1 or 2
- Patients who have undergone resection are eligible provided residual disease is evident on imaging
- No clinical or radiographic evidence of progression of extracranial disease in month prior to enrollment on study.
Who cannot join
- Major psychiatric illness
- Lesions in brainstem, midbrain, pons, medulla
- Patient who have undergone complete resection of all known infratentorial disease
- Patients with leptomeningeal metastases
- Patients with hepatic metastases
- Patients with metastases from the following primary tumors are ineligible: Small Cell Lung Cancer; rena Cell Carcinoma; Melanoma; Sarcoma
- Previous cranial irradiation
Trial locations and contacts
1 site in 1 country.
Israel1 site
Radiotherapy Department, TASMC
Tel Aviv, 64239
Marina Gurman, 972-3-6974098, marinag@tasmc.health.gov.il
Vika Gurevich, 972-3-6947285, vikag@tasmc.health.gov.il
About this study
Official title: A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
The aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. Patterns of failure following treatment of metastases that arise in the posterior fossa have not been reliably defined. Although most would agree that radiosurgery alone is not sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver less than WBI as an "expanded port" beyond the SRS volume.
The current study acknowledges that at least two therapeutic modalities are requisite for patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In so doing, it is hoped that the putative advantage derived from foregoing whole brain irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of excessive surpratentorial failure.
Read the detailed description
SCHEMA:
- Posterior Fossa Irradiation as defined by diagnostic MRI and CT simulation.
- 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
- Radiosurgical boost (with dose titrated to parameters of RTOG 9005).
- Contrast enhanced MRI will be obtained at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
- The Mini Mental Status Examination will be used to evaluate global cognitive function at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
- Conditions
- Neoplasm Metastasis
- Being tested
- Irradiation plus Stereotactic Radiosurgery
- Keywords
- irradiation, stereotactic radiosurgery, posterior fossa, cerebellar metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irradiation plus Stereotactic RadiosurgeryProcedure or surgery
Posterior Fossa Irradiation-total dose of 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
Radiosurgical boost-total dose administered to each lesion will be titrated to the size of the metastatic focus as follows:
Maximum Tumor Diameter:<2.0 cm; Assigned Dose:24 Gy. Maximum Tumor Diameter:2.1-3.0 cm;Assigned Dose:18 Gy. Maximum Tumor Diameter:3.1-4.0 cm;Assigned Dose:15 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Exp | Experimental | Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI \& Mini Mental Status Examination Receives: Procedure: Irradiation plus Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases.
Measured: 1 year
Secondary outcomes (1)
To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases.
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 posted28 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ben Corn, Prof., Principal investigator, Radiotherapy Department, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781209
- Sponsor's protocol ID
- TASMC - 08 - BC - 270 - CTIL
- Status last verified
- Oct 2008
- First submitted
- 26 Oct 2008
- Last updated
- 28 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
- ClinicalTrials.gov ID
- NCT00781209
- Acronym / sponsor ID
- TASMC - 08 - BC - 270 - CTIL
- Conditions
- Neoplasm Metastasis
- Keywords
- irradiation, stereotactic radiosurgery, posterior fossa, cerebellar metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 Oct 2008 (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.
The aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. Patterns of failure following treatment of metastases that arise in the posterior fossa have not been reliably defined. Although most would agree that radiosurgery alone is not sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver less than WBI as an "expanded port" beyond the SRS volume.
The current study acknowledges that at least two therapeutic modalities are requisite for patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In so doing, it is hoped that the putative advantage derived from foregoing whole brain irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of excessive surpratentorial failure.
Detailed description
SCHEMA:
- Posterior Fossa Irradiation as defined by diagnostic MRI and CT simulation.
- 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
- Radiosurgical boost (with dose titrated to parameters of RTOG 9005).
- Contrast enhanced MRI will be obtained at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
- The Mini Mental Status Examination will be used to evaluate global cognitive function at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exp | Experimental | Procedure: Irradiation plus Stereotactic RadiosurgeryPosterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI \& Mini Mental Status Examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed malignant disease
- All primary tumors exclusive of:
- 1-3 intraparenchymal metastases
- Age ≥18 years
- RPA(14) 1 or 2
Key exclusion criteria (7 listed)
- Major psychiatric illness
- Lesions in brainstem, midbrain, pons, medulla
- Patient who have undergone complete resection of all known infratentorial disease
- Patients with leptomeningeal metastases
- Patients with hepatic metastases
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 |
|---|---|---|
| Irradiation plus Stereotactic RadiosurgeryPosterior Fossa Irradiation-total dose of 37.5 Gy in 2.5 Gy fractions administered via conformal beams. Radiosurgical boost-total dose administered to each lesion will be titrated to the size of the metastatic focus as follows: Maximum Tumor Diameter:<2.0 cm; Assigned Dose:24 Gy. Maximum Tumor Diameter:2.1-3.0 cm;Assigned Dose:18 Gy. Maximum Tumor Diameter:3.1-4.0 cm;Assigned Dose:15 Gy. | Procedure or surgery | Exp |
Primary outcome
To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases.
Time frame: 1 year
1 secondary outcome
To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2008.
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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.
Ben Corn, Prof. principal investigator
Radiotherapy Department, TASMC
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 Irradiation plus Stereotactic Radiosurgery in people with Neoplasm Metastasis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 11 inclusion and 7 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 28 Oct 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben Corn, Prof. (972-3-6947285, bencorn@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases. (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 28 Oct 2008.