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Clinical Trial: Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| 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 | Procedure: radiation therapy | Phase I |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of External Beam Radiotherapy Using Conformal 3-Dimensional Treatment Planning in Patients With 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Chemotherapy
- No prior chemotherapy for lung cancer
Endocrine therapy
- No prior endocrine therapy for lung cancer
Radiotherapy
- No prior radiotherapy for lung cancer
Surgery
Location Information
Kenneth Rosenzweig, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
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.
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.
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002484
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Small Businesses (Centers for Disease Control and Prevention)

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