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Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002484
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: radiation therapy Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 1991
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: external beam radiotherapy
Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks.
Radiation: radiation therapy

Primary Outcome Measures :
  1. Determine the maximum dose of external beam irradiation [ Time Frame: 2 years ]

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


  • 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



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • No prior biologic therapy for lung cancer


  • No prior chemotherapy for lung cancer

Endocrine therapy

  • No prior endocrine therapy for lung cancer


  • No prior radiotherapy for lung cancer


  • No prior surgery for lung cancer

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 identifier (NCT number): NCT00002484

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Study Chair: Kenneth Rosenzweig, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
Armstrong J, Zelefsky M, Burt M, et al.: Acute toxicity of high dose 3-dimensional conformal radiation therapy (3-DCRT) for non small-cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1171, 348, 1993.

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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00002484    
Other Study ID Numbers: 91-121
CDR0000077300 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms