- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01767935
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.
OUTLINE:
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forente stater, 27157
- Comprehensive Cancer Center of Wake Forest University
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Pathologically (histologically or cytologically) confirmed metastatic disease with a new tumor involving or abutting bone that has the clinical and imaging features of metastatic disease
- If the nature of the metastatic disease has been previously documented, index tumor to be treated does not require further documentation (i.e., biopsy)
- Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief Pain Inventory [BPI], despite analgesic therapy) OR the subject is experiencing intolerable side effects that preclude analgesic use (resulting in pain of 4 or above, as measured by BPI)
Pain must be from one or two painful metastatic sites in the bone (additional less painful metastatic sites may be present)
- Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, magnetic resonance imaging (MRI), or ultrasound (US) imaging
- Metastatic tumors must be amenable to cryoablation with CT or MRI
- If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
- Patients must have stable use of hormonal therapy for two weeks prior to study registration and two weeks prior to cryoablation procedure)
- Stable use of pain medications (no changes within two weeks of cryoablation procedure)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >= 2 months
- Platelets > 50,000/mm^3
- International normalized ratio (INR) >= 1.5
- Patients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- Patients who are taking antiplatelet or anticoagulation medication (e.g., aspirin, ibuprofen, low molecular weight heparin [LMWH] preparations) must be able to discontinue such treatment prior to the cryoablation procedure for an appropriate amount of time; at least 5 days should be allowed after discontinuation of aspirin, Coumadin, clopidogrel, and dipyridamole; at least 12 hours should be allowed after discontinuation of LMWH preparations
- Patients must be clinically suitable for cryoablation therapy
- Patients must be clinically suitable for radiation therapy
- Patients must be able to understand and willing to sign a written informed consent document
Exclusion Criteria:
- Patients with a diagnosis of leukemia, lymphoma, or myeloma
- Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
- Patients who have undergone prior ablation treatment or radiation therapy of the index tumor
- Patients who have received chemotherapy within 14 days prior to and 14 days after cryoablation procedure
- Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement
- Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder
- Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor
- Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
- Patients with uncontrolled coagulopathy or bleeding disorders
- Patients who are pregnant, nursing, or who wish to become pregnant during the study
- Patients with active, uncontrolled infection
- Patients with serious medical illnesses, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within six months prior to study entry
- Patients who are concurrently participating in any other experimental studies that could affect the primary endpoint of this study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Treatment (cryosurgery and radiation therapy)
Patients undergo cryosurgery.
Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Hjelpestudier
Andre navn:
Gjennomgå strålebehandling
Andre navn:
Undergo cryosurgery
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Tidsramme: 24 hours
|
Numerical scores (0-10) from the BPI will be used to measure pain levels.
Higher scores denotes worse outcome.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Tidsramme: Baseline to 24 weeks
|
Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.
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Baseline to 24 weeks
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Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Tidsramme: Up to 24 weeks
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Up to 24 weeks
|
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Pain After Cryosurgery, as Measured by the BPI
Tidsramme: Up to 24 weeks
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Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures.
Higher scores denotes worse outcome
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Up to 24 weeks
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Number of Participants Who Survived
Tidsramme: Up to 24 weeks post-cryosurgery
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Count of participants that survived.
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Up to 24 weeks post-cryosurgery
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: David Childs, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00020528
- P30CA012197 (U.S. NIH-stipend/kontrakt)
- NCI-2012-02087 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- CCCWFU 97212 (Annen identifikator: Wake Forest University Health Sciences)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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