- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00484978
Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
A Single Center Prospective Phase II Study: Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study Purpose
Treatment strategies for recurrent brain metastasis
Limited clinical data support interventions for recurrent BM such as WBRT, re-operation or SRS, depending on previous treatments (6, 45, 48). Two retrospective analyses looked at a total of 130 non-small cell lung cancer (NSCLC) patients with recurrent BM after resection (6, 45). ,Recurrence happened at the original site in approximately two/thirds of the patients and at other sites for the remainders; Re-resection had a significant effect on prolonged survival compared to patients who did not undergo it (p=0.001). A small subgroup of these patients underwent a third resection with a median survival of 42 months. A more recent study looked at resection of BM that had previously been treated with SRS (48). Sixty-one patients with 1-3 previously treated BM recurred and underwent resection. Major neurological morbidity occurred in 2% and no mortality was observed. A multivariate analysis showed that higher RPA class, focal treatment (surgery or SRS), and treatment of new additional lesions significantly affected survival. Re-operation of a previously focally treated BM provided long-term control and positive impact on survival. Additionally, confirming the pathological diagnosis in a recurrent lesion after SRS is important, as radiation necrosis can occur in 2.3%-8.6% of the patients, a condition that requires a different treatment approach than that for recurrent metastasis (5, 10, 14).
Surgery and radiation therapy are important components in the complex treatment of BM and can prolong survival and improve the quality of life. Patients, who develop brain metastasis after WBRT remain with limited options. A resection will diminish the local disease significantly; however adjuvant radiation might further increase the control rate. We plan to evaluate the addition of a stereotactic radiosurgery (SRS) boost to the resection cavity both as adjuvant and salvage procedure in patient, who underwent resection of a BM and previously received WBRT or decline WBRT.
Study Design
The study is designed to observe patients for feasibility, efficacy and toxicity:
Patient Enrollment Informed Consent will be obtained and then eligibility screening will be assessed using Inclusion/ Exclusion criteria. A patient who appears to meet ALL eligibility requirements will be asked to participate in the study.
Variables Measured The primary end point will be evaluated following obtaining follow up neuro-imaging (contrast Brain CT or MRI).
The secondary end points will be measured as follows:
- Evaluation of CT and MRI by neuro-radiologist. - Individual response: comparison between pre-treatment and follow-up MRI performed at 2-3 months intervals or according to clinical indication.
- Side effects during and following the treatment, as well as self reported (or otherwise obtained) absence of side effects.
Pre-Procedure
Screening process:
Patients with known systemic malignancy, who underwent surgical resection of a brain metastasis and fulfill the eligibility criteria specified for this study (see inclusion/exclusion criteria)
Imaging:
All patients will undergo a contrast CT and MRI brain imaging in preparation of the treatment.
Neurological Baseline Assessment:
A standard neurological baseline examination shall take place. The neurological examination will include the following:
- Cognitive function ( Mini Mental Status)
- Cranial nerves
- Motor Strength
- Deep tendon reflexes
- Plantar response
- Sensory
- Coordination/Gait
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Tel Aviv, Israel
- Rekruttering
- Tel Aviv Sourasky Medical Center
-
Kontakt:
- Lina Vizelman
- Telefonnummer: 972-3-6974098
- E-mail: linav@tasmc.health.gov.il
-
Kontakt:
- Andrew A Kanner, MD
- Telefonnummer: 972-3-6974273
- E-mail: andrewk@tasmc.health.gov.il
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient must have undergone surgical resection of a brain metastasis
- Patients with no more than 3 brain metastases on contrast MRI.
- Previous WBRT for brain malignancy, except patients with melanoma, renal cell carcinoma.
- Adult patient aged > 18.
Patient must be in adequate general health, as indicated by:
- Karnofsky performance status equal or greater than 60.
- The absence of a concomitant life-threatening disease other than the malignancy.
- Patient must understand the investigational nature of this study and sign informed consent form, approved by the Institutional Review Board.
Exclusion Criteria:
- Pregnancy
- Patients unable or unwilling to follow protocol requirements
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Improved local tumor control after resection
Tidsramme: 6months and 12 months
|
6months and 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall survival Quality of life
Tidsramme: QoL 3-6-12months and overall survival
|
QoL 3-6-12months and overall survival
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Andrew A Kanner, MD, Tel Aviv Medical Center, affiliated Tel Aviv University
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07-056 TASMC
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