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

NCT00128999 | Completed Phase 1 DMC

• 1 other identifier: LU-11-0035
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

radiation therapy

Outcome Measures

Primary Outcomes (1)

• safety and adverse effects

Secondary Outcomes (1)

• efficacy and survival

Interventions

Intensity-Modulated Radiation Therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Positive supraclavicular noce (N2) or malignant pleural effusion

Sponsors & Collaborators

• Alberta Health services: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1V2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Wilson Roa, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 11, 2005
• Study Start: September 1, 2003
• Study Completion: August 1, 2007
• Last Updated: February 9, 2010

Record last verified: 2007-10

Locations

CA (1)