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Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer

1. februar 2010 oppdatert av: The First Affiliated Hospital of Guangzhou Medical University

Feasibility of Video-Assisted Thoracoscopic Surgery for Clinical Stage IIIA Non-Small Cell Lung Cancer

The purpose of this study is to examine the feasibility of video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer. Success is defined as VATS major pulmonary resection with SND without conversion. If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.

Studieoversikt

Status

Ukjent

Forhold

Ikke-småcellet lungekreft

Intervensjon / Behandling

Fremgangsmåte: VATS

Detaljert beskrivelse

Video-assisted or minimally invasive surgery has become the standard approach for many abdominal surgical operations such as cholecystectomy and fundoplication. With respect to the thorax, video-assisted thoracoscopic surgery (VATS) is the accepted technique for biopsy of the lung and pleura and surgical treatment of pneumothorax. A VATS lobectomy with systematic node dissection (SND) for non-small cell lung cancer (NSCLC) has been gradually introduced by many thoracic surgeons since it was first performed in 1995 by McKenna and associates. They reported that the survival rate for stage I lung cancer is similar between lobectomies done by VATS and by thoracotomy. Although minimally invasive surgery certainly sounds good, it is problematic if it decreases patient's safety or the oncological treatment's effect. Hence, the feasibility and safety of SND by VATS remain controversial. In many institutions, the indication for VATS major pulmonary resection is limited to clinical stage I or II. For the application of the procedure to clinical stage IIIA, it remains controversial. Recently, Watanabe et al. did a retrospective study aimed at determining the outcome of patients with cN0-pN2 NSCLC who underwent VATS major pulmonary resection with SND versus the outcome after major pulmonary resection with SND by open thoracotomy. It demonstrated that VATS major pulmonary resection with SND was a feasible approach to management of cN0-pN2 NSCLC without loss of curability. It was unnecessary to convert the VATS approach to thoracotomy in order to do SND even if pN2 disease is revealed during VATS major pulmonary resection. The purpose of this study is to know whether VATS major pulmonary resection with SND for clinical stage IIIA non-small cell lung cancer is possible.

Studietype

Intervensjonell

Registrering (Forventet)

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina, 510120
    - Rekruttering
    - Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
    - Ta kontakt med:
      
      Daoyuan Wang, MD
      
      Telefonnummer: +86-20-83337792
      
      E-post: wangdy@vip.163.com
    - Ta kontakt med:
      
      Wenlong Shao, MD
      
      Telefonnummer: +86-20-83337792
      
      E-post: myfriends2003@126.com
    - Hovedetterforsker:
      
      Jianxing He, MD, FACS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
Stage IIIA (T1-3, N2, M0): N2 disease confirmed by any of the following: Mediastinoscopy; Bronchoscopy with fine-needle aspiration or esophagoscopy; or PET scan
ECOG performance status 0-1
Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
Renal: Creatinine clearance greater than 60 ml/min
Cardiovascular: Cardiac function normal

Exclusion Criteria:

Severe complications or infections
Pregnant or breast-feeding women
Clinically significant heart disease
Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Ikke-randomisert
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer (Success is defined as VATS major pulmonary resection with SND without conversion). Tidsramme: 2 month	2 month

Sekundære resultatmål

Resultatmål	Tidsramme
To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay) Tidsramme: 6 months	6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Etterforskere

Studiestol: Jianxing He, MD, FACS, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2008

Primær fullføring (Forventet)

1. august 2009

Studiet fullført (Forventet)

1. desember 2009

Datoer for studieregistrering

Først innsendt

13. mars 2009

Først innsendt som oppfylte QC-kriteriene