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1.
BMC Cancer ; 19(1): 430, 2019 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-31072314

RESUMO

BACKGROUND: The spine is the most frequent location of bone metastases. Local treatment aims at palliation of pain and, given the increased likelihood of long-term cancer survival, at local control. Kyphoplasty and intraoperative radiotherapy (Kypho-IORT) provided instantaneous pain relief in 70% of patients at the first day after the intervention and resulted in local control rates of > 93% at 1 year in a recently conducted phase I/II trial. To assess its clinical value, we designed a phase III trial which tests Kypho-IORT against the most widespread standard-of-care, external beam radiotherapy (EBRT), in patients with painful vertebral metastases. METHODS: This phase III study includes patients ≥50 years of age with up to 4 vertebral metastases and a pain score of at least 3/10 points on the visual/numeric analogy scale (VAS). Patients randomized into the experimental arm (A) will undergo Kypho-IORT (Kyphoplasty plus IORT with 8 Gy prescribed to 13 mm depth). Patients randomized into the control arm (B) will receive EBRT with either 30 Gy in 10 fractions or 8 Gy as a single dose. The primary end point is pain reduction defined as at least - 3 points on the VAS compared to baseline at day 1. Assuming that 40% of patients in the Kypho-IORT arm and 5% of patients in the control arm will achieve this reduction and 20% will drop out, a total of 54 patients will have to be included to reach a power of 0.817 with a two-sided alpha of 0.05. Secondary endpoints are evaluation of the percentage of patients with a pain reduction of at least 3 points at 2 and 6 weeks, local tumor control, frequency of re-intervention, secondary fractures/sintering, complication rates, skin toxicity/wound healing, progression-free survival (PFS), overall survival (OS) and quality of life. DISCUSSION: This trial will generate level 1 evidence on the clinical value of a one-stop procedure which may provide instantaneous pain relief, long-term control and shortened intervals to further adjuvant (systemic) therapies in patients with spinal metastases. TRIAL REGISTRATION: Registered with ClinicalTrials.gov, number: NCT02773966 (Registration date: 05/16/2016).


Assuntos
Dor do Câncer/terapia , Cuidados Intraoperatórios/métodos , Cifoplastia/métodos , Manejo da Dor/métodos , Neoplasias da Coluna Vertebral/terapia , Dor do Câncer/diagnóstico , Dor do Câncer/etiologia , Ensaios Clínicos Fase III como Assunto , Terapia Combinada/métodos , Fracionamento da Dose de Radiação , Humanos , Pessoa de Meia-Idade , Medição da Dor , Intervalo Livre de Progressão , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias da Coluna Vertebral/complicações , Neoplasias da Coluna Vertebral/mortalidade , Neoplasias da Coluna Vertebral/secundário , Coluna Vertebral/efeitos da radiação , Coluna Vertebral/cirurgia
2.
Spine J ; 18(5): 776-781, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-28962909

RESUMO

BACKGROUND CONTEXT: Spinal metastases occur in 30%-50% of patients with systemic cancer. The primary goals of palliation are pain control and prevention of local recurrence. PURPOSE: This study aimed to test the safety and efficacy of a combined modality approach consisting of kyphoplasty and intraoperative radiotherapy (Kypho-IORT). STUDY DESIGN/SETTING: Kyphoplasty and intraoperative radiotherapy was a prospective, single-center phase I/II trial. Patients were enrolled in a classical 3+3 scheme within the initial phase I, where Kypho-IORT was applied using a needle-shaped 50 kV X-ray source at three radiation dose levels (8 Gy in 8-mm, 8 Gy in 11-mm, and 8 Gy in 13-mm depth). Thereafter, cohort expansion was performed as phase II of the trial. The trial is registered with clinicaltrials.gov, number NCT01280032. PATIENT SAMPLE: Patients aged 50 years and older with a Karnofsky Performance Status of at least 60% and with one to three painful vertebral metastases confined to the vertebral body were eligible to participate. OUTCOME MEASURES: The primary end point was safety as per the occurrence of dose-limiting toxicities. The secondary end points were pain reduction, local progression-free survival (L-PFS), and overall survival (OS). METHODS: Pain was measured using the visual analog scale (VAS) and local control was assessed in serial computed tomography or magnetic resonance imaging scans. RESULTS: None of the nine patients enrolled in the phase I showed dose-limiting toxicities at any level and thus, 52 patients were subsequently enrolled into a phase II, where Kypho-IORT was performed at various dose levels. The median pain score significantly dropped from 5 preoperatively to 2 at the first postoperative day (p<.001). Of 43 patients who reported a pre-interventional pain level of 3 or more, 30 (69.8%) reported a reduction of ≥3 points on the first postoperative day. A persistent pain reduction beyond the first postoperative day of ≥3 points was seen in 34 (79.1%) patients. The 3, 6, and 12 month L-PFS was excellent with 97.5%, 93.8%, and 93.8%. The 3, 6, and 12 months OS was 76.9%, 64.0%, and 48.4%. CONCLUSION: Kyphoplasty and intraoperative radiotherapy is safe and immediately provided sustained pain relief with excellent local control rates in patients with painful vertebral metastases.


Assuntos
Cifoplastia/métodos , Recidiva Local de Neoplasia/prevenção & controle , Complicações Pós-Operatórias/epidemiologia , Radioterapia/métodos , Neoplasias da Coluna Vertebral/cirurgia , Idoso , Terapia Combinada , Feminino , Humanos , Cifoplastia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/efeitos adversos , Manejo da Dor/métodos , Radioterapia/efeitos adversos , Neoplasias da Coluna Vertebral/radioterapia , Neoplasias da Coluna Vertebral/secundário
3.
Radiat Oncol ; 10: 30, 2015 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-25636703

RESUMO

BACKGROUND: Current therapeutic standard for locally advanced rectal cancer is the neoadjuvant radiochemotherapy with total mesorectal excision. Diarrhoea is the main acute side effect, induced by the dose to the small-bowel, frequently leading to a treatment modification. Aim of this study was to analyse the differences between the irradiated small-bowel volumes and the occurrence of acute diarrhea during combined radiochemotherapy for rectal cancer. METHODS: 45 patients treated with a neoadjuvant radiochemotherapy (three-field box 50.4 Gy; Cetuximab, Capecitabine, Irinotecan) for locally advanced rectal cancer within a prospective phase I/II study were evaluated. Based on the dose-volume histograms, the small-bowel volumes receiving doses of 5, 10 … 45 Gy (V5, V10 …V45) were calculated and compared with the prospectively documented small- bowel toxicities. RESULTS: There was a statistically significant difference between irradiated small-bowel volumes and the severity of therapy related diarrhoea. The strongest validity concerning the risk of developing a grade 2-3 diarrhoea was seen at a dose level of 5 Gy (V 5) with a small-bowel volume of 291.94 cc. Patients with V 5 > 291.94 cc had significantly more often grade 2-3 diarrhoea, than patients with V5 below this cut-off value (82% vs. 29%; p < 0.0001). CONCLUSIONS: In the inverse treatment planning of rectal caner patients the small-bowel volume receiving 5 Gy should be limited to about 300 cc.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Quimiorradioterapia/efeitos adversos , Diarreia/etiologia , Intestino Delgado/patologia , Terapia Neoadjuvante/efeitos adversos , Lesões por Radiação/etiologia , Neoplasias Retais/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Camptotecina/administração & dosagem , Camptotecina/análogos & derivados , Capecitabina/administração & dosagem , Cetuximab/administração & dosagem , Diarreia/diagnóstico , Feminino , Seguimentos , Humanos , Intestino Delgado/efeitos dos fármacos , Intestino Delgado/efeitos da radiação , Irinotecano , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/terapia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Prognóstico , Estudos Prospectivos , Lesões por Radiação/diagnóstico , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia de Intensidade Modulada/métodos , Neoplasias Retais/patologia
4.
Tumori ; 98(4): 434-40, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23052158

RESUMO

AIMS AND BACKGROUND: Kyphoplasty is an effective procedure providing structural stability and pain alleviation in vertebral metastases. To prevent early regrowth, patients typically receive postoperative fractionated radiotherapy, which is associated with long treatment duration. Therefore, we established a new approach to deliver intraoperative radiotherapy during kyphoplasty to shorten the treatment time and reach structural stability and sterilization of the metastases (Kypho-IORT). METHODS AND STUDY DESIGN: For Kypho-IORT, a 50 kV X-ray source with a specially designed applicator was used. A radiation dose of 8 Gy in 5 mm distance was delivered. After radiation the device was removed and the kyphoplasty was completed according to the standard procedure. Since August 2009, 18 patients with instable or painful spinal metastases received Kypho-IORT. The median age was 63 years (range, 43-73). RESULTS: Kypho-IORT was successfully performed in 18 of 21 vertebral lesions (86%). No severe complications occurred during or early after IORT. The median pain score using a visual analogue scale decreased from 5/10 before the procedure to 2.5/10 at day 1 (P <0.001) and to 0/10 six weeks after the procedure (P = 0.001). Imaging studies were available for 15 of 18 patients. Stable disease within the irradiated vertebral body was seen in 14 patients (93%) and local progressive disease in one patient (7%). No re-irradiation due to local progressive disease or pain recurrence was necessary within the median follow-up of 4.5 months. CONCLUSIONS: Kypho-IORT is well tolerated without severe side effects and provides fast improvement of pain. Although stable disease was seen in 93% of the patients, a longer follow-up is necessary to assess the effectiveness. A dose escalation study to establish the maximally tolerated dose has been initiated.


Assuntos
Cifoplastia , Neoplasias da Coluna Vertebral/radioterapia , Neoplasias da Coluna Vertebral/cirurgia , Adulto , Idoso , Feminino , Humanos , Período Intraoperatório , Estimativa de Kaplan-Meier , Cifoplastia/métodos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Dosagem Radioterapêutica , Radioterapia Adjuvante , Neoplasias da Coluna Vertebral/secundário , Resultado do Tratamento
5.
Int Orthop ; 36(6): 1255-60, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22270861

RESUMO

PURPOSE: To evaluate whether this new method is clinically applicable after theoretical and cadaver testing. METHODS: The incidence of spinal metastases requiring therapy is increasing, due to enhanced life expectancy. Due to results from studies with epidural compression a combined surgical and radiation therapy is often chosen. Minimal invasive cement augmentation is an increasingly used technique, due to fast pain relief and immediate stabilisation. On the other hand, stereotactic radiosurgery is considered to provide a more durable response and better local disease control than conventional radiotherapy with the application of higher doses. Therefore the combination of cement stabilisation and simultaneous intra-operative radiation with immediate stabilisation and high-dose radiation could be an interesting therapeutic option. The results of a clinical feasibility study are presented. RESULTS: 17 patients could be treated with the new method. In two patients (10%) intra-operative radiation could not be applied. No surgical interventions for complications were required. CONCLUSIONS: Summarizing Kypho-IORT is technically feasible with an intra-operative risk profile comparable to sole kyphoplasty and a shorter treatment time and hospitalisation for the patients compared to conventional multifraction radiation. Radiation could not be applied in 10% of cases due to technical difficulties. The results of this feasibility study permit further evaluation of this new technique by a dose escalation study which is currently in preparation.


Assuntos
Braquiterapia/métodos , Cuidados Intraoperatórios/métodos , Cifoplastia/métodos , Radioterapia Adjuvante/métodos , Neoplasias da Coluna Vertebral/terapia , Braquiterapia/efeitos adversos , Cadáver , Cimentação , Estudos de Viabilidade , Feminino , Humanos , Complicações Intraoperatórias , Cifoplastia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Radioterapia Adjuvante/efeitos adversos , Neoplasias da Coluna Vertebral/secundário
6.
Int J Radiat Oncol Biol Phys ; 81(4): 1114-9, 2011 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-20934272

RESUMO

PURPOSE: Approximately 30% of patients with cancer receive bone metastases, of which 50% are in the spine. Approximately 20% present with unstable lesions requiring surgical intervention, followed by fractionated radiotherapy over 2-4 weeks to prevent early regrowth. Because of the limited survival time of patients with metastatic cancer, novel treatment concepts shortening the overall treatment time or hospitalization are desirable. In this study, we established a novel approach for intraoperative radiotherapy during kyphoplasty (Kypho-IORT), a method that combines stabilizing surgery and radiotherapy within one visit, after estimating the percentage of eligible patients for this treatment. METHODS AND MATERIALS: To estimate the percentage of eligible patients, 53 planning CTs (897 vertebrae) of patients with spinal metastases were evaluated. The number of infiltrated vertebrae were counted and classified in groups eligible or not eligible for Kypho-IORT. The Kypho-IORT was performed in a donated body during a standard balloon kyphoplasty using the INTRABEAM system and specially designed applicators. A single dose of 10 Gy (in 10 mm) was delivered over 4 min to the vertebra. This was verified using two ionization chambers and a Monte Carlo simulation. RESULTS: The estimation of eligible patients resulted in 34% of the evaluated patients, and thus 34% of patients with instable spinal metastases are suitable for Kypho-IORT. This study shows also that, using the approach presented here, it is possible to perform an IORT during kyphoplasty with an additional 15 min operation time. The measurement in the donated body resulted in a maximum dose of 3.8 Gy in the spinal cord. However, the Monte Carlo depth dose simulation in bone tissue showed 68% less dose to the prescription depth. CONCLUSION: We present for the first time a system using an x-ray source that can be used for single-dose IORT during kyphoplasty. The described Kypho-IORT can decrease the overall treatment time for up to 34% of patients who usually receive radiotherapy for spinal metastases.


Assuntos
Cifoplastia , Neoplasias da Coluna Vertebral/radioterapia , Idoso , Idoso de 80 Anos ou mais , Braquiterapia/instrumentação , Braquiterapia/métodos , Feminino , Humanos , Período Intraoperatório , Masculino , Método de Monte Carlo , Seleção de Pacientes , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Fraturas da Coluna Vertebral/cirurgia , Neoplasias da Coluna Vertebral/secundário , Fatores de Tempo
7.
Radiat Oncol ; 5: 11, 2010 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-20149237

RESUMO

BACKGROUND: Instable and painful vertebral metastases in patients with progressive visceral metastases present a common therapeutic dilemma. We developed a novel approach to deliver intraoperative radiotherapy (IORT) during kyphoplasty and report the first treated case. METHODS/RESULTS: 60 year old patient with metastasizing breast cancer under chemotherapy presented with a newly diagnosed painful metastasis in the 12th thoracic vertebra. Under general anaesthesia, a bipedicular approach into the vertebra was chosen with insertion of specially designed metallic sleeves to guide the electron drift tube of the miniature X-ray generator (INTRABEAM, Carl Zeiss Surgical, Oberkochen, Germany). This was inserted with a novel sheet designed for this approach protecting the drift tube. A radiation dose of 8 Gy in 5 mm distance (50 kV X-rays) was delivered. The kyphoplasty balloons (KyphX, Kyphon Inc, Sunnyvale) were inflated after IORT and polymethylmethacrylate cement was injected. The whole procedure lasted less than 90 minutes. CONCLUSION: In conclusion, this novel, minimally invasive procedure can be performed in standard operating rooms and may become a valuable option for patients with vertebral metastases providing immediate stability and local control. A phase I/II study is under way to establish the optimal dose prescription.


Assuntos
Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Radioterapia/métodos , Neoplasias da Coluna Vertebral/radioterapia , Neoplasias da Coluna Vertebral/cirurgia , Vertebroplastia , Neoplasias da Mama/patologia , Terapia Combinada , Feminino , Humanos , Período Intraoperatório , Pessoa de Meia-Idade , Neoplasias da Coluna Vertebral/secundário , Vértebras Torácicas/cirurgia
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