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Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Royal Marsden - London
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005071
  Purpose

RATIONALE: Diagnostic procedures and treatment-planning systems may affect outcome in patients suspected of having lung cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of two types of diagnostic and treatment-planning systems in patients who are suspected of having lung cancer.


Condition Intervention
Cancer-Related Problem/Condition
Lung Cancer
Procedure: biopsy
Procedure: bronchoscopy
Procedure: computed tomography

MedlinePlus related topics:   Cancer    Lung Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized
Official Title:   A Pilot Study Leading to a Randomized Trial Comparing Outcomes in Patients With Suspected Lung Cancer Investigated in the Conventional Locally (LO) Based (BA) Chest Clinic Compared With a Centralized 2 Stop Pathway (LOBA 2STOP)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1998

Detailed Description:

OBJECTIVES: I. Compare the survival rate of patients with suspected lung cancer when diagnosed and managed using the conventional locally based approach versus a new centralized system using a 2 stop diagnosis. II. Compare the resection rate in both diagnostic arms. III. Assess the quality of service given in both diagnostic arms.

OUTLINE: This is a randomized study. Patients present to a general practitioner where they are referred to the local chest clinic. Patients are seen by the chest physician and, if deemed eligible, are randomized between 2 diagnostic arms. Arm I (Conventional Locally Based Diagnosis): Patients undergo bronchoscopy and CT scan as appropriate, and then are discussed or referred by individual chest physicians, as is the current practice. The optimal period for diagnosis and discussion of management plans is 6 weeks. Arm II (Centralized 2 Stop Diagnosis): Patients undergo CT scan the following Monday morning. The consultant radiologist advises the most appropriate diagnostic test (e.g., bronchoscopy or percutaneous needle biopsy) to be done that same Monday. A tissue diagnosis is available Thursday morning for the multidisciplinary meeting attended by the chest physician, medical and clinical oncologists, and a surgeon, and the patient treatment plan is decided. Quality of life is assessed at baseline and at 6 weeks. Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 252-315 patients will be accrued for this study within 2 years.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Possible diagnosis of lung cancer Fit enough for bronchoscopy and CT scan

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005071

Locations
United Kingdom, England
Royal Marsden Hospital    
      Sutton, England, United Kingdom, SM2 5PT

Sponsors and Collaborators
Royal Marsden - London

Investigators
Study Chair:     Mary O'Brien, MD     Royal Marsden - Surrey    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067676, RMNHS-PATHWAY, EU-99039
First Received:   April 6, 2000
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00005071
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer  
stage II non-small cell lung cancer  
limited stage small cell lung cancer  
quality of life  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Quality of Life
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008




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