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Study Using Induction Chemotherapy and Intensity-Modulated Radiation Therapy Guided by Combined CT and PET Imaging for Patients With Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00128999
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
AHS Cancer Control Alberta

Brief Summary:
Lung cancer is the leading cause of cancer-related mortality in the United States (US) and Canada. Because of the high incidence and mortality of this disease, small improvements in the management of this disease translates into large numbers of patients having improved outcomes after treatment. Radiation therapy is widely used to treat patients with lung cancer. However, the radiation dose to the tumor has been limited by the proximity of normal structures to the tumor, such as the lung, the spinal cord and the esophagus. The normal structures must not be exposed to excessive radiation doses. A new technique, called intensity-modulated radiotherapy delivers radiation to tumors such that the normal structures around the tumor are exposed to less radiation than previously achievable. This technique is already used to treat head and neck cancers. This study will use this technique to deliver more intensified radiation to the lung tumor after the patient receives two cycles of chemotherapy. A new imaging technique, called positron emission tomography (PET), has been found to be more sensitive and specific at detecting the extent of the tumor in the lung than the older imaging technique of computed tomography (CT). This study will use both the PET and CT to target the radiation beams. Following treatment, the patients will be followed up to assess the side effects of normal tissues and response of the tumor to the treatment.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Procedure: Intensity-Modulated Radiation Therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation Study Using Induction Chemotherapy and Intensity-Modulated Radiation Therapy Guided by Combined CT and PET Imaging for Patients With Non-Small Cell Lung Cancer
Study Start Date : September 2003
Actual Study Completion Date : August 2007

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Primary Outcome Measures :
  1. safety and adverse effects

Secondary Outcome Measures :
  1. efficacy and survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage I-III
  • Unresectable non-small cell lung cancer (NSCLC)
  • EEV1 equal to or greater than 1.0L

Exclusion Criteria:

  • Positive supraclavicular noce (N2) or malignant pleural effusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128999


Locations
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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1V2
Sponsors and Collaborators
Alberta Health Services
Investigators
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Principal Investigator: Wilson Roa, MD AHS Cancer Control Alberta

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ClinicalTrials.gov Identifier: NCT00128999    
Other Study ID Numbers: LU-11-0035
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: October 2007
Keywords provided by AHS Cancer Control Alberta:
radiation therapy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases