- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Comprehensive Cancer Center of Wake Forest University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
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Etudes annexes
Autres noms:
Subir une radiothérapie
Autres noms:
Undergo cryosurgery
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Délai: 24 hours
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Numerical scores (0-10) from the BPI will be used to measure pain levels.
Higher scores denotes worse outcome.
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24 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Délai: Baseline to 24 weeks
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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
Délai: Up to 24 weeks
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Up to 24 weeks
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Pain After Cryosurgery, as Measured by the BPI
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: David Childs, Wake Forest University Health Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00020528
- P30CA012197 (Subvention/contrat des NIH des États-Unis)
- NCI-2012-02087 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- CCCWFU 97212 (Autre identifiant: Wake Forest University Health Sciences)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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