Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors (FACPT)
15. april 2010 opdateret af: The First Affiliated Hospital of Guangzhou Medical University
A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors
The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection.
This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours.
Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies.
Recently, RFA has been proposed as a viable option for the treatment of pulmonary malignancies.
Experimental studies in animal tumor models have confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary malignancies.
Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response.
We designed a prospective clinical trial aimed at assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the treatment of lung malignancies.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
48
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
- Rekruttering
- Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
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Kontakt:
- Jianxing He, MD, FACS
- Telefonnummer: +86-20-83337792
- E-mail: drjianxing.he@gmail.com
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Ledende efterforsker:
- Jianxing He, MD, FACS
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Kontakt:
- Xin Xu, MD
- Telefonnummer: +86-20-83337792
- E-mail: yichunrenjia@126.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 76 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients with pulmonary malignancies are not candidates for surgical resectionpatients.
Beskrivelse
Inclusion Criteria:
- adult (> 18 years) male or female patient
- patient has biopsy-proven NSCLC or lung metastasis
- patient has been rejected for surgery and has been considered unfit for radiation therapy
- each 6 cm or smaller in greatest diameter of tumor, by CT scan
- tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
- tumors are accessible by percutaneous route
- patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
- patient has signed written informed consent prior to any study specific procedures.
Exclusion Criteria:
- patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
- patient has more than 3 tumors / lung
- patient has at least one tumor > 6 cm in greatest diameter
- tumor is associated with atelectasis or obstructive pneumonitis
- patient has renal failure requiring hemodialysis or peritoneal dialysis
- patient has active clinically serious infection
- patient has history of organ allograft
- patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
- patient is pregnant or breast-feeding
- patient has ECOG performance status > 2
- patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Radiofrequency Ablation
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Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Progression-free survival
Tidsramme: 3 months
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3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Samlet overlevelse
Tidsramme: 3 måneder
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3 måneder
|
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Antal deltagere med uønskede hændelser som et mål for sikkerhed og tolerabilitet
Tidsramme: 30 dage
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30 dage
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jianxing He, MD, FACS, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2009
Primær færdiggørelse (Forventet)
1. december 2010
Studieafslutning (Forventet)
1. juni 2011
Datoer for studieregistrering
Først indsendt
12. april 2010
Først indsendt, der opfyldte QC-kriterier
15. april 2010
Først opslået (Skøn)
16. april 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. april 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2010
Sidst verificeret
1. december 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FAHG20100201
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