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Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002484   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
October 1991
 
 
 
Complete list of historical versions of study NCT00002484 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-Small Cell Lung Cancer
A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER

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.

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.

Phase I
Interventional
Treatment
Lung Cancer
Radiation: radiation therapy
 
Armstrong J, Raben A, Zelefsky M, Burt M, Leibel S, Burman C, Kutcher G, Harrison L, Hahn C, Ginsberg R, Rusch V, Kris M, Fuks Z. Promising survival with three-dimensional conformal radiation therapy for non-small cell lung cancer. Radiother Oncol. 1997 Jul;44(1):17-22.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002484
 
CDR0000077300, MSKCC-91121, NCI-V91-0198
Memorial Sloan-Kettering Cancer Center
 
Study Chair: Kenneth Rosenzweig, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP