- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00746655
SBRT + TACE for Primary Hepatocellular Carcinoma
23 dicembre 2015 aggiornato da: Dwight Heron, University of Pittsburgh
A Study of Stereotactic Body Radiation Therapy (SBRT) in Combination With Cisplatin Transcatheter Arterial Chemoembolization (TACE) for Primary Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine the feasibility and toxicity of combining SBRT and TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Panoramica dello studio
Stato
Ritirato
Condizioni
Descrizione dettagliata
Patients who are poor surgical candidates could potentially benefit from non-surgical alternatives such as stereotactic body radiation therapy (SBRT).
SBRT is an ideal approach to minimize radiation exposure to the normal liver while maximizing the dose to the tumor.
Transarterial chemoembolization (TACE) is the combined use of intra-arterial chemotherapy and particulate arterial embolization.
This technique is typically used to make unresectable liver lesions amenable to resection, for palliation in cases of extra-hepatic spread or recurrence, or for symptomatic relief.
The combination of intraarterial chemotherapy with vessel embolization makes logical sense since primary and secondary liver tumors derive up to 95% of their blood supply from the hepatic artery, while the normal liver gains the majority of its blood supply from the portal system.
Thus, using transarterial chemoembolization it is possible to achieve high intratumor drug concentrations followed by local ischemia, allowing uninvolved liver to be spared.
This study is to determine that these standard of care therapies combined to improve the quality of life for the patient population.
Tipo di studio
Interventistico
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15232
- Hillman Cancer Center
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Pittsburgh, Pennsylvania, Stati Uniti, 15232
- UPMC Cancer Pavilion
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Pittsburgh, Pennsylvania, Stati Uniti, 15232
- UPMC Shadyside Radiation Oncology
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- UPMC Presbyterian/Montifore
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Male or female patients ≥ 18 years of age
- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix III)
- HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria. All of the following criteria must be met or a biopsy is required: • Known cirrhosis or chronic HBV or HCV infection, • Hypervascular liver masses >2 cm, and either serum AFP > 400 ng/ml, or • AFP >three times normal and doubling in value in the antecedent 3 months.
- The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a combined maximum tumor volume of ≤ 180 cm3.
- No prior radiotherapy to the liver.
- Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan.
- Cirrhotic status of Child-Pugh class A or B (Appendix I)
- Patient's lesions are deemed unresectable.
- Patient's tumor burden or medical comorbidities disqualify them for transplant OR the patient qualifies for transplant but refuses the operation OR patients planned for TACE as a bridge to transplant operation.
- Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) ≤ 1.5 or a PT/PTT within normal limits. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
- Other baseline labs must meet the following criteria: total bilirubin <3mg/dl, albumin>2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be <1.8mg/dl or a creatinine clearance >50ml/min.
- Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
Exclusion Criteria:
- Renal failure requiring hemo- or peritoneal dialysis
- Uncontrolled inter-current illness (except Hepatitis) including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted.
- A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement.
- History of an active connective tissue disorder.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects.
- Total portal vein occlusion.
- Extensive liver tumor burden, defined as more than 75% of the liver.
- Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.
- Patients with uncontrolled distant disease will be excluded from this protocol. Those with controlled systemic disease will still be eligible.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: SBRT / TACE
|
The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period.
The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks.
The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,
Altri nomi:
. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2.
After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
To determine the feasibility and toxicity of combining SBRT and TACE for HCC.
Lasso di tempo: Until disease progression
|
Until disease progression
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To evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Lasso di tempo: Until disease progression
|
Until disease progression
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
To determine local response of combination therapy with PET/CT and CT only.
Lasso di tempo: Every 8 weeks
|
Every 8 weeks
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To evaluate the progression free interval associated with this local regional therapy.
Lasso di tempo: Until disease progression
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Until disease progression
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To determine if SBRT and TACE will be able to bridge patients to transplant that were initially ineligible.
Lasso di tempo: Until disease progression
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Until disease progression
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Dwight E Heron, MD, University of Pittsburgh Medical Center
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2009
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
2 settembre 2008
Primo inviato che soddisfa i criteri di controllo qualità
3 settembre 2008
Primo Inserito (Stima)
4 settembre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 dicembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 dicembre 2015
Ultimo verificato
1 dicembre 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 08-042
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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