- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01850316
Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy
A Phase II Study for the Treatment of Unresectable or Medically Inoperable Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy (SBRT) in British Columbia
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Radiotherapy is not considered standard of care practice for patients for inoperable hepatocellular carcinoma despite the tumour's inherent radiosensitivity. The major challenge has been improving radiation delivery without exceeding dose limits of the surrounding normal liver. Recent technological advances with tumour localization and targeting, imaging, treatment planning and delivery have allowed for safe delivery of radiation with tumorcidal effect and minimal treatment-related toxicity.
This study has three specific aims:
1. To develop, validate, and quality test HDR Stereotactic Body Radiotherapy (SBRT) Gated RapidArc technique for application in human liver tumours. And furthermore, to test whether HDR SBRT Gated RapidArc can be efficiently and safely delivered to a very large patient population previously ineligible for any therapy (HCC patients with tumours >5cm).
3. To determine if 11C-choline/18F-FDG CT-PET or perfusion CT imaging (that characterize changes in tumour proliferation, glycolysis, and vasculature, respectively) can provide practical non-invasive biomarkers of tumour response, local tumour control, or normal tissue toxicity.
4. To determine if immunologic studies of pre- and post-treatment blood samples can provide biomarkers of tumour response, local and systemic tumour control, or triggers for normal tissue toxicity.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z4E6
- BC Cancer Agency
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age > 18 years old
Multi-phase CT scan of the liver within 8 weeks of radiation planning demonstrating:
- Liver tumours must be > 5 cm
- No more than 5 discrete liver tumours may be present
- Normal liver > 700 cc
- FDG-PET scan within 12 weeks prior to radiation planning
- Patients must have HCC diagnosed by either: i) pathological confirmation, or ii) intrahepatic vascular enhancement of the lesion demonstrated by at least two imaging modalities, or iii) intrahepatic vascular enhancement of the lesion demonstrated by one imaging modality if AFP > 200 in the setting of liver cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus guidelines)
- Liver HCC must be deemed unresectable as determined by an experienced liver surgeon, or the patient must be medically inoperable or refuse surgery, and extra-hepatic metastases must not be present (Patients with potential resectable tumours who are deemed unresectable based on medical inoperability or simultaneous extra-hepatic metastases will be eligible to receive SBRT).
- Patients must be discussed in a multidisciplinary setting where opinions regarding radiofrequency ablation, various embolotherapies, and targeted biologics are considered, but not eligible for. Patients must have recovered from the effects of previous therapies before SBRT.
- Eastern Clinical Oncology Group performance status 0,1 or 2 or a Karnofsky performance status of ≥ 60
Adequate organ function as assessed by the following blood work:
- Hemoglobin ≥ 90 g/L
- Absolute neutrophil count ≥ 1.0 bil/L
- Platelets ≥ 50 bil/L
- AST and ALT not to exceed 2x upper limit of normal
Child-Turcotte-Pugh assessment (within 8 weeks of treatment date):
- Bilirubin ≤ 3 mg/dL (< 50 µmol/L)
- Albumin above 28 g/L
- INR < 1.7 and/or correctable with vitamin K (unless on anticoagulation therapy)
- No ascites or encephalopathy
- Child-Turcotte-Pugh score must be ≤ 7 (see Table 1 in Section 2.1)
- BCLC Stage B or C (portal venous invasion or liver hilum nodal disease only)
- No extra-hepatic disease and life expectancy > 6 months
- No chemotherapy concurrent with radiotherapy
- Previous treatment(s) with radiofrequency ablation, surgery, TACE, Y90, percutaneous ethanol injection, or chemotherapy are not exclusion criteria provided that recurrence has been documented.
- Patient signs a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative. A translator will be provided if the patient has a language barrier.
- Treatment plans meet acceptable dose constraints and Liver Veff is ≤ 0.55
Exclusion Criteria:
- Patients with active hepatitis, encephalopathy, or ascites related to liver failure
- Female patients who are pregnant (verify with blood test if patient is pre-menopausal). Pre-menopausal patients may also not become pregnant during participation in this study.
- Prior external beam radiation to the upper abdomen
- Patients with distant metastases or extrahepatic nodal progression (patients with portal venous thrombosis and liver hilum nodal involvement remain eligible)
- Patients who have < 700 cc of normal liver.
- Child-Turcotte-Pugh scores > 7
- BCLC Stage A, C (N1 and/or M1), D
- Prior gastric, duodenal, or variceal bleed within the past 2 months
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Stereotactic Ablative Radiotherapy
Preferred target coverage of 40 Gy: coverage and total dose determined by irradiated liver volume NTCP (normal tissue complication probability) nomogram and OAR dose limits
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Preferred target coverage of 40 Gy: coverage and total dose determined by irradiated liver volume NTCP (normal tissue complication probability) nomogram and OAR dose limits
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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One year local progression-free rate
Časové okno: Approximately 1 year
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Approximately 1 year
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Progression-free survival
Časové okno: To be reviewed in approximately 8 years; upon study completion
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To be reviewed in approximately 8 years; upon study completion
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Overall Survival
Časové okno: To be reviewed in approximately 8 years; upon study completion
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To be reviewed in approximately 8 years; upon study completion
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Treatment related toxicity
Časové okno: To be reviewed in approximately 8 years; upon study completion
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To be reviewed in approximately 8 years; upon study completion
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Quality of Life
Časové okno: To be reviewed in approximately 8 years; upon study completion
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To be reviewed in approximately 8 years; upon study completion
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Cytokine response to radiation and association with complications
Časové okno: To be reviewed in approximately 8 years; upon study completion
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To be reviewed in approximately 8 years; upon study completion
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Functional imaging with 11C-choline/18F-FDG CT-PET and perfusion CT to that characterize treatment-related effects
Časové okno: To be reviewed in approximately 8 years; upon study completion
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To be reviewed in approximately 8 years; upon study completion
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Roy Ma, MD, British Columbia Cancer Agency
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- H13-00481
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Klinické studie na Stereotactic Ablative Radiotherapy
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