Lung Cancer Clinical Trial
Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.
Full Description
OBJECTIVES:
Determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer.
Determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients.
Determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy.
Determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change.
OUTLINE: This is a dose escalation study.
Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks.
Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 20% of patients experience dose-limiting toxicity.
Patients are followed at 1 month and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Clinical stage T1-4, N0-2, M0
Clinical stage T1-2, N0-1 must be medically inoperable
No distant metastases on history and physical exam, CBC, screening profile, CT or MRI of brain, CT of chest and abdomen (including adrenals and liver), and bone scan
No pleural effusions
Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease
Diffuse pulmonary infiltrates thought to represent benign disease allowed only if representative lesion samples are proven by biopsy or cytology not to contain cancer
No diffuse bronchoalveolar carcinoma
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 70-100%
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
Other:
No other malignancy within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical carcinoma
No other medical illness that cannot be adequately controlled with appropriate therapy or that is considered severe enough to preclude a radical treatment approach
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior biologic therapy for lung cancer
Chemotherapy
No prior chemotherapy for lung cancer
Endocrine therapy
No prior endocrine therapy for lung cancer
Radiotherapy
No prior radiotherapy for lung cancer
Surgery
No prior surgery for lung cancer
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There is 1 Location for this study
New York New York, 10021, United States
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